Clinical Research Directory

iCorMicA - Stratified Medicine in Angina

The iCorMicA study is a multicentre, prospective, randomised, double-blind, sham-controlled, parallel-group, end-point trial and registry. The investigators seek to determine whether stratified medical therapy guided by an adjunctive interventional diagnostic procedure (IDP) during the invasive management of patients with known or suspected angina but no obstructive coronary artery disease improves symptoms, wellbeing, cardiovascular risk and clinical outcomes.

Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study

This study aims to evaluate the sensitivity and specificity of a multi-sensor wireless pressure microcatheter for the diagnosis of CMD in patients with ANOCA/INOCA, using quantitative myocardial perfusion imaging of cardiac magnetic resonance (CMR) as a reference.

Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is: Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life? Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention. Participants will: * Undergo percutaneous coronary intervention and coronary function testing in the intervention arm * Undergo percutaneous coronary intervention in the control arm

CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction

The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol: Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues? Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure. Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up. A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol. A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.

The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study (SLEEP-CMD)

In a cohort of patients with suspected myocardial ischemia undergoing sleep studies, the objectives of this study were: 1. To determine the association between various obstructive sleep apnea (OSA)-related nocturnal hypoxemia parameters and coronary microvascular dysfunction (CMD) in patients with suspected myocardial ischemia. 2. To compare the predictive value of nocturnal hypoxemia parameters versus the traditional Apnea-Hypopnea Index (AHI) for coronary microvascular dysfunction. 3. To evaluate the prognostic value of nocturnal hypoxemia parameters in predicting Major Adverse Cardiovascular Events (MACE) during the follow-up period. 4. To explore the potential mediating roles of inflammatory and oxidative stress biomarkers in the relationship between nocturnal hypoxemia parameters and coronary microvascular dysfunction.

The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease

People with chronic kidney disease (CKD) often experience faster aging of the heart and blood vessels, which raises the risk of heart problems beyond traditional factors like high blood pressure or cholesterol. One early sign is reduced blood flow in the tiny vessels that supply the heart, measured by a positron emission tomography (PET) scan using a marker called myocardial flow reserve (MFR). In CKD, ongoing inflammation and abnormal blood vessel growth can damage these small vessels, leading to heart stiffness and weaker heart function. A kidney transplant offers a unique chance to study how better kidney function and reduced inflammation affect heart health. The observational RESTORE study ("Impact of Renal Transplant on Coronary Microvascular Function in Patients with Advanced CKD") will measure heart blood flow and function before and after transplant. The study will test whether: 1. Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD. 2. Kidney transplant improves heart blood flow and function. 3. Lower inflammation after transplant leads to better heart health. By understanding how kidney disease and inflammation affect the heart-and how transplant may reverse these effects-this research could help guide future treatments to better protect heart health in patients with CKD.

Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)

The goal of this clinical trial is to that Sodium-glucose cotransporter 2 inhibitors treatment will improve Coronary Microvascular Disease with anginal symptoms associated with non-obstructive coronary disease in women. The main questions it aims to answer are: Aim 1: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves coronary microvascular disease in women with no evidence of epicardial obstructive coronary artery disease. Aim 2: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves angina symptoms and other quality of life measurements associated with the improvement of CFR. AIM 3: Identify the effect of Sodium-glucose cotransporter 2 inhibition on inflammation pathways and markers of systemic Research will compare Brezavvy to placebo Participants will: * Take study drug or placebo for 12 weeks * Stress Cardiac magnetic resonance imaging * 12 lead electrocardiograms * Complete questionnaires

Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction. The main questions it aims to answer are: 1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation) 2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire 3. Preliminary data on the fidelity and clinical efficacy of MICROFIT Participants will be randomized to either MICROFIT + Usual Care, or Usual Care group. Participants in both arms of the trial will: * Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months * Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months * Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months. Participants in the intervention arm of the study will: 1. Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves: * 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home * 1:1 sessions with a dietician to support them with improvements in diet. 2. Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist 3. Undergo an interview at the end of the study to discuss their experiences of participation in the study 4. Receive a debrief on their investigation results and progress made at the end of their study Participants in the Usual Care arm of the study will: 1. Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction. 2. Receive a debrief on their investigation results and progress made at the end of their study 3. Undergo a 'taster' session with the personal trainer to discover what the intervention involves.

Inorganic Nitrate as a Treatment for ANOCA: NO-ANOCA

The purpose of this study is to see if inorganic nitrate in the form of beetroot juice helps blood flow and physical fitness in women with ANOCA and CMD. The main questions it aims to answer are: AIM 1: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase cardiac perfusion and improve quality of life compared to placebo. AIM 2: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase physical fitness and reduce angina and dyspnea symptoms compared to placebo. Exploratory AIM 3: Test the hypothesis that fourteen days of nitrate rich beetroot juice will improve vascular health and function. Participants will: * Take study beverage for 4 weeks total. * Stress Cardiac magnetic resonance imaging and 12 lead electrocardiograms * Complete questionnaires * Cycling exercise test * Non invasive vascular testing * Blood draws

A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.

The coronary angiography-derived index of microcirculatory resistance (caIMR) can be used to provide a binary assessment whether patients（with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, and without cardiomyopathy or obstructive epicardial coronary artery disease） have microcirculatory dysfunction, using a cutoff value of 25. This study aims to evaluate the binary classification performance of caIMR in two specific groups of patients: (1) those with caIMR values between 20 and 30, and (2) those with diffuse disease. We will do this by looking at differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes over a three-year period.

INOCA-NA a Local Prospective Registry

The present study has the following objectives: 1. To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital; 2. To stratify in INOCA endotypes patients according to the presence or absence of alternative (i.e. non obstructive CAD) causes of myocardial ischemia detected during CA clinically indicated through physiology tests; 3. to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up

Nebivolol ANOCA Treatment Randomized Trial

To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.

Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention

The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention. The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention. Participants will answer survey questions about their clinical outcomes for 2 years by telephone.