Clinical Research Directory

Common Femoral Vein-to-Artery Diameter Ratio for Detection of Elevated LVEDP

This prospective cross-sectional diagnostic accuracy study enrolled patients undergoing coronary angiography and left heart catheterization at Burapha University Hospital, Thailand. The diameters of the common femoral vein and common femoral artery were measured using ultrasonography, and the common FVD/FAD ratio was calculated. LVEDP, measured during left heart catheterization, served as the reference standard. An elevated LVEDP (\>16 mmHg) was defined as volume overload. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis.

Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT

Myocardial perfusion single-photon emission computed tomography (SPECT) is a well-established functional imaging technique for the assessment of coronary artery disease. Recent developments in cadmium-zinc-telluride (CZT) camera technology have enabled significant reductions in acquisition time while improving image quality. Positron emission tomography (PET) myocardial imaging remains the reference standard for the quantitative assessment of myocardial blood flow (MBF) and myocardial flow reserve (MFR); however, its use is limited by high costs and restricted availability. This exploratory study aims to evaluate the feasibility of using CZT-SPECT/CT imaging as an alternative approach by assessing the absolute quantification of myocardial tracer uptake, expressed as standardized uptake values (SUV), both at rest and during stress. The primary objective is to compare the ratio of stress-to-rest SUV obtained from SPECT with MFR values measured using PET imaging. Patients under cardiology care at the University Hospital of Orléans who are scheduled for diagnostic coronary angiography or coronary CT angiography will be invited to participate. The study procedures will be integrated into their routine clinical workflow. On Day 0, participants will undergo a PET myocardial perfusion study using Rubidium-82, including measurement of MBF and MFR, with concomitant administration of 99mTc-tetrofosmin under pharmacological stress using the same vasodilator agent. A stress CZT-SPECT/CT acquisition will then be performed immediately after the PET scan. Within seven days of the initial evaluation, participants will undergo a rest CZT-SPECT/CT acquisition. Quantitative analysis of myocardial tracer uptake will subsequently be performed to derive SUV values. The overall goal of this feasibility study is to generate preliminary data to support the design of a larger-scale clinical study. Ultimately, the study seeks to determine whether standard CZT-SPECT/CT imaging could provide a simpler, faster, and more widely accessible alternative to PET myocardial perfusion imaging for functional myocardial assessment.

DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease

DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.

Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI

This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT). A total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization. The primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite/probable stent thrombosis, and ischemic stroke) at 12 months post-PCI. If non-inferiority is confirmed, the study will further test whether 50 mg aspirin reduces clinically relevant bleeding events (BARC type 2, 3, or 5) better than the standard dose. The study is sponsored by the First Hospital of Jilin University and will be carried out in 10-15 tertiary hospitals across China. Its findings will provide evidence for optimizing aspirin dosing in post-PCI DAPT.

Short-Term Dual Antiplatelet Therapy With Early Transi-tion to Low-dose Antiplatelet Monotherapy Using Ti-cagRelor in Chronic Coronary Artery Disease

This is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). The primary endpoint is a composite of cardiovascular death, all-cause death, myocardial infarction, disabling stroke, target lesion revascularization (TLR), and major bleeding. The study aims to evaluate whether the short DAPT strategy reduces ischemic events while maintaining bleeding safety.

OPtimization of Antiplatelet Therapy After the intervenTION of de Novo Coronary Artery Lesions With Drug-Coated Balloons

Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved clinical outcomes, long-term studies have demonstrated that stent-related complications-including late restenosis, very late thrombosis, impaired vascular compliance due to permanent metal residue, and bleeding risk associated with prolonged dual antiplatelet therapy (DAPT)-have yet to be fundamentally resolved. Drug-coated balloon (DCB) has emerged as a "metal-free" alternative strategy, delivering antiproliferative drugs to the vessel wall during balloon expansion, with the aim of reducing metal residue, promoting vascular healing, and lowering the incidence of long-term adverse events. Multiple high-quality studies have validated the safety and efficacy of DCB in the setting of in-stent restenosis (ISR) and small-vessel de novo lesions. The international DCB consensus has explicitly incorporated ISR and small-vessel disease into the category of established indications. Recent studies have demonstrated that, in small-vessel lesions, DCB is comparable to second-generation DES with respect to target lesion revascularization (TLR) and major adverse cardiovascular events (MACE), while conferring a lower risk of long-term stent-related complications. These advances have prompted relevant expert panels to publish operational standards and indication guidelines for DCB. Meanwhile, the research focus of DCB is gradually expanding toward "large-vessel de novo lesions." This lesion subset is typically characterized by a reference vessel diameter ≥2.75-3.0 mm, high lesion burden, and impaired vascular compliance. Several international studies have found that, under conditions of adequate lesion preparation-defined as residual stenosis \<30%, absence of severe dissection, and sufficient lesion expansion-DCB treatment of large-vessel de novo lesions can yield satisfactory outcomes. China has rapidly followed suit, with experts revising the national expert consensus in 2024 to refine the application of drug-coated balloons in coronary stenotic lesions. Owing to the absence of permanent metallic stent residue and the short duration of local drug action, DCB theoretically permits the use of a less intensive antiplatelet regimen. However, clinical trial evidence regarding the optimal antiplatelet strategy following DCB treatment remains lacking. This study aims to investigate whether, among patients with chronic coronary syndrome (CCS) undergoing DCB treatment, 1 month of dual antiplatelet therapy post-procedure is non-inferior to 6 months of dual antiplatelet therapy with respect to target vessel failure (TVF) at 1 year.

Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.

Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography

Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano). On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques.

"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI

This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.

A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Chinese Adults With Chronic Coronary Syndrome

The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. Researchers will compare selatogrel to a placebo (a look-alike substance that contains no drug). Participants will stay at the research clinic for 3 or 4 days (2 or 3 nights), during which time they will receive a single dose of selatogrel or placebo. A telephone call for post-trial safety follow-up will be done 30-40 days after the participant leaves the clinic.

Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

The purpose of this study is to compare the effect of prasugrel plus low-dose aspirin versus high dose aspirin alone (300mg) and versus low dose aspirin alone (75 mg) in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling

Even with standard treatments like statins, patients with coronary artery disease often face a residual risk of further heart events. This risk is largely driven by ongoing inflammation and unstable fatty plaques in the heart's blood vessels. Icosapent ethyl (IPE) is a highly purified prescription medication known to improve cardiovascular outcomes, but its detailed effects on the heart's structure and inflammation in everyday clinical practice need further exploration. This study is a prospective, observational, real-world study designed to evaluate the effectiveness of IPE in patients with Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS). The study plans to enroll 420 patients who will be followed for 12 months. Based on their routine clinical prescriptions, participants will be grouped into a control group (receiving standard cardiovascular care, including statins) and an exposure group (receiving standard care plus IPE). Throughout the 1-year follow-up, researchers will conduct regular blood tests and advanced heart imaging. The main goal is to determine if adding IPE to standard therapy leads to a more significant reduction in inflammation. Additionally, the study will observe how IPE affects the stability of coronary plaques and the healing process of ventricular remodeling in a real-world clinical setting.

Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.

Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes

The CCS-plastics is an investigator-initiated, prospective, multicenter study of patients undergoing coronary CT angiography (CCTA) for suspected or known chronic coronary syndromes (CCS) referred to invasive coronary angiography for clinical indication. Patients identified as eligible for the protocol will be asked for written consent to participate in the study. The patients' dossiers will be uploaded and transmitted to the core laboratory for analysis. The routine management of the CCS patients will not be affected and all patients will be managed according to current standards. Invasive coronary angiography and coronary blood samples will be performed following the current standards, guidelines, and indications. During invasive coronary angiography, coronary blood samples will be collected per standard of care and sent to a centralized, specialized core laboratory for MNPs and biomarkers analysis. The central core lab for MNPs analyses will be the University of Campania Luigi Vanvitelli, Naples, Italy. The identification, quantification (concentration, mcg/ml), and typing of plastic particles will be performed in each tube for each patient, using pyrolysis-gas chromatography-mass spectrometry (Py-GC/MS) and laser direct infrared (LDIR) spectroscopy. The CCTA will be centrally analyzed by Centro Cardiologico Monzino to evaluate qualitative and quantitative plaque features. Patients will be followed clinically at 1 and 3 years per standard of care.

Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries

Determine the long-term efficacy of clopidogrel compared with aspirin in reducing heart or brain attacks in patients with stable heart disease

Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention

The purpose of this study is to evaluate the clinical utility of zastaprazan compared to proton pump inhibitors (PPIs) in patients receiving dual antiplatelet therapy (DAPT) including clopidogrel after percutaneous coronary intervention (PCI), by comparing their effects on platelet reactivity.

Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)

The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.

Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome

This study is a prospective, randomized, sham-controlled, participant- and assessor-blinded, parallel-group clinical trial designed to evaluate the clinical efficacy, mechanistic effects, and safety of right dorsolateral prefrontal cortex (DLPFC) closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome (CCS) and comorbid anxiety disorder. Participants will be randomly assigned in a 1:1 ratio to active neurofeedback or sham feedback. The intervention consists of 4 weeks of treatment, with 20 sessions in total (1 session per weekday, approximately 20 minutes per session). The primary endpoint is the between-group difference in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after treatment. Secondary endpoints include HAMA score and HAMA response rate at the end of treatment, as well as neurophysiological measures collected during Session 1, including right DLPFC activation, heart rate (HR), and heart rate variability (HRV). Exploratory long-term follow-up will assess cardiovascular and bleeding outcomes through 4 years after randomization.

Reversal to Normoglycemia by Treating Prediabetes

Prediabetes is a precursor to diabetes, but compared with diabetes, much less is known about prediabetes. Prediabetes is defined based on a blood sample measuring long-term average glucose levels. In the Danish population, about 7% have prediabetes, and roughly one in five will develop diabetes within five years. In the US, significantly more people have this condition - about 38% of the adult population - and it is reasonable to expect a growing global prevalence over the years. Diabetes is associated with various microvascular diseases, traditionally referred to as diabetic complications, such as diabetic retinopathy, diabetic nephropathy, and diabetic neuropathy. However, it has been shown that some of these conditions are already present in some individuals with prediabetes, even though this condition does not meet the diagnostic criteria for diabetes. Several metabolic changes are often seen in people with prediabetes, including high cholesterol, hypertension, increased inflammatory markers, and obesity. Additionally, there is a possible link between prediabetes and the occurrence of fat accumulation in the liver. These risk factors are also believed to be associated with the development of coronary atherosclerosis. In individuals with coronary atherosclerosis there is an overrepresentation of prediabetes. Therefore, the investigators would like to investigate whether this group of people might benefit from having their long-term average glucose levels reduced to normal from prediabetes using glucose-lowering medication, which is approved for use in people with diabetes and has also shown a cardioprotective effect in individuals without diabetes. The medications that will be used for this purpose are: Semaglutide, administered once weekly as a subcutaneous injection. The dose will be gradually increased at 4-week intervals up to a maximum of 2.4 mg. If this is insufficient, it may be considered to start Dapagliflozin (Forxiga), 10 mg tablet daily. Both treatments are approved for use in Europe but are not currently used to treat prediabetes. A total of 108 individuals with prediabetes and coronary atherosclerosis who consent to participate in the trial will be randomly assigned (1:1) to two groups: 1. Interventional therapy arm: Participants will attend visits at Aarhus University Hospital and begin glucose-lowering treatment. Additionally, any hypertension or high cholesterol will be optimized according to current guidelines. They will be offered lifestyle counselling. Participants will have their blood pressure measured regularly and, if necessary, blood samples are drawn to optimize the above. 2. Conventional therapy arm: Participants will receive standard treatment either at the hospital or from their general practitioner, without any influence from the trial and without starting trial-related medication. Furthermore, a third group of 50 participants with coronary atherosclerosis and normal long-term average glucose levels will be included. All trial participants will, at inclusion, be examined for the presence of diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, and liver fat accumulation. This will be done through blood samples, urine samples, nerve examinations, and liver ultrasound. In addition, height, weight, waist circumference, body muscle and fat composition, pulse, and blood pressure will be measured. The third group will then conclude their participation. The interventional therapy arm will begin the described intervention, which lasts for one year. After one year, the intervention period will end. Both randomized groups will then be examined by blood samples, urine samples, liver ultrasound, height, weight, waist circumference, body muscle and fat composition, pulse, and blood pressure. One year later, the above examinations will be repeated, except for the liver ultrasound. This will mark the end of the trial.

Personalized Evaluation of Susptected Myocardial Ischemia

This study aims to assess whether the use of clinical risk models, known as Clinical Likelihood (CL) models, can reduce the need for diagnostic examinations without negatively impacting quality of life or prognosis after 12 months in patients with stable new onset chest pain. Additionally, the project will evaluate a newly developed method called Laser Speckle Contrast Imaging for measuring function and oxygen content in the smallest blood vessels (microvasculature) of the hand, which may also reflect blood flow and oxygen content in the microvasculature of the heart.

Effect of Intensive Lipid-Lowering Therapy on Coronary Atherosclerotic Plaque Progression in Young and Middle-Aged Patients With Chronic Coronary Syndrome

This is a multicenter, open-label, parallel-group, randomized trial to determine if intensive lipid-lowering therapy (goal for LDL-C \<1.0 mmol/L and ≥50% reduction frome baseline) could delay progression of coronary atherosclerotic obstructive leisions compared with guideline recommended lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L and ≥50% reduction frome baseline) among participants between 18-60 years old with non-invasively managed chronic coronary syndrome (at least one lesion with a 50%-70% stenosis).

Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \[15O\]H2O cardiac PET/CT in patients with symptomatic chronic coronary syndrome.

Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2

A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.