Clinical Research Directory

Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community

The goal of this observational study is to evaluate whether a contactless camera-based technology, called remote photoplethysmography (rPPG), can accurately measure cardiovascular parameters and estimate cardiovascular risk in adults aged 30 years and older living in a community setting in Semanan, Jakarta. This study aims to determine if rPPG can be used as a simple and accessible tool for early cardiovascular screening. The main questions it aims to answer are: 1. Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements? 2. Do cardiovascular risk estimates generated by rPPG (such as ASCVD risk and Framingham heart age) correspond to risk calculations obtained using conventional clinical and laboratory methods? Researchers will compare results obtained from rPPG-based facial video scans with results from standard medical assessments, including blood pressure measurements, heart rate evaluation, and laboratory tests for cholesterol levels, to determine the level of agreement and accuracy. Participants will: 1. Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system 2. Receive standard clinical assessments, including blood pressure and heart rate measurements 3. Provide basic health information (such as age, sex, smoking status, and treatment history) Undergo simple laboratory testing for cholesterol levels This study is expected to help determine whether rPPG can be used as a reliable, non-invasive, and scalable screening tool for cardiovascular risk in community and primary healthcare settings.

Coronary Sinus Reducer Therapy for Persisting Angina

Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless-steel mesh device designed to create a controlled narrowing of the coronary sinus (CS). By increasing CS pressure, CSR implantation may improve myocardial perfusion and reduce anginal symptoms, although the physiological mechanisms underlying this effect remain incompletely understood. REDUCE-ANGINA is a prospective observational study investigating the hemodynamic effects of CSR implantation in 25 patients with refractory angina and advanced CAD. The study evaluates the interaction between coronary sinus hemodynamics and coronary arterial blood flow before and after CSR implantation. The main study endpoints include changes in coronary sinus pressure, coronary flow reserve, microvascular resistance reserve, and absolute microvascular resistance from baseline to 6 months, measured using continuous flow thermodilution during saline-induced coronary hyperemia.

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD. Within the aerobic exercise methods, there is evidence showing that high-intensity interval training (HIIT) increases FMD to a greater extent than moderate-intensity training (MIT) in these patients. Notably, in a recent review, our research group found that only studies performing long bouts of HIIT (long HIIT: higher than 1 min) found a greater effect on FMD, while no differences were found in those studies using short bouts of HIIT (short HIIT: ≤ 1 min) and MIT. However, no experimental studies comparing the effect of long HIIT, short HIIT, and MIT on endothelial function, as well as other predictors of mortality, such as cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels or parasympathetic branch activity, have been performed. Therefore, the main objective of this project will be to compare the effect of the three aerobic exercise methods on endothelial function, as measured by FMD, in patients with IHD. Complementarily, the effect of aerobic exercise, depending on the exercise method, on different mortality predictors will be compared. For this purpose, a multicentre randomised study will be carried out (2 hospitals in Elche and one in Alicante). Assessors will be blinded to the patients allocation. Participants will be aware about their allocation in the experimental groups due to the nature of the study. A total of 132 men and women with IHD (66 per sex), diagnosed between three and 12 months before the start of the intervention, aged between 45 and 75 years, and without limitations for the practice of exercise training, will be recruited. All patients will train 3 days a week for 12 weeks. Participants will be assessed before the intervention (i.e., pre), at 6 weeks of training (i.e., mid) and after the intervention (i.e., post). Physiological and psychological variables will be registered in the assessment periods. Training intensity will be individually prescribed based on the cardiopulmonary exercise test (CPET). Intensity exercise will be adapted after the first part of the intervention. Analysis of covariance will be used to compare the values of the three groups after the intervention for the continuous variables, including the pre-intervention value as a covariate, while a logistic regression model will be used for the categorical variables.

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.

Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease

The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.

Coronary Sinus Reducer in Coronary Microvascular Disease

Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.

Effect of Beta-blockers on Coronary Flow and Resistance in Patients With ANOCA

The goal of this clinical trial is to learn whether beta-blockers can improve coronary blood flow and reduce resistance in patients with angina and no obstructive coronary arteries (ANOCA). The main questions it aims to answer are: * Do beta-blockers improve coronary blood flow in patients with ANOCA? * Do beta-blockers reduce coronary microvascular resistance in these patients? Researchers will compare a beta-blocker to a placebo to see if the medication has measurable effects on coronary circulation. Participants will: * Receive a beta-blocker or a placebo * Undergo specialized heart tests (such as coronary flow and resistance measurements) before and after treatment.

Angina After PCI: a Systems Medicine Study

Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent. This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future). We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI. Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.