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Coronary Disease clinical trials

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NCT ID: NCT05731687 Recruiting - Clinical trials for Coronary Artery Disease

Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy

Hybrid DEB
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation. Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies. The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach. Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow < Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry. Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.

NCT ID: NCT05730621 Recruiting - Clinical trials for Coronary Artery Disease

A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease

Start date: January 11, 2023
Phase: Phase 4
Study type: Interventional

This study is to compare the effects of sarpogrelate sustained release /aspirin combination therapy versus aspirin on blood viscosity in the patients with peripheral arterial disease and coronary artery disease

NCT ID: NCT05726019 Recruiting - Clinical trials for Coronary Artery Disease

Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome

COCAR
Start date: February 5, 2022
Phase: Phase 2
Study type: Interventional

The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization. Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.

NCT ID: NCT05716997 Recruiting - Clinical trials for Coronary Artery Disease

Relationship Between Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty

PROBE-FFR
Start date: December 20, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this prospective observational study is to learn about in patients who need percutaneous coronary intervention for coronary artery disease. The main questions it aims to answer are: - Fractional flow reserve according to coronary angiography findings after coronary artery balloon angioplasty - Differences in fractional blood flow reserve before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon Participants will voluntarily consent to the study after being fully informed about the study and given ample opportunity to ask questions.

NCT ID: NCT05713565 Recruiting - Clinical trials for Coronary Artery Disease

A Digital Care Solution for Coronary Artery Disease Patients

Start date: February 6, 2023
Phase: N/A
Study type: Interventional

This is a single center, randomized clinical trial (RCT), recruiting 200 patients with coronary artery disease (CAD) who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik, Iceland. The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients. Patients will be randomized to receive either the standard of care (SoC) alone or SoC with the addition of the digital app. The digital app will include remote patient monitoring and a patient support program specific for CAD patients. The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients' quality of life.

NCT ID: NCT05713201 Recruiting - Coronary Disease Clinical Trials

Outcomes After PCI of the Aneurysmatic Right Coronary Artery

RIGHT-MARE
Start date: November 1, 2022
Phase:
Study type: Observational

This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA).

NCT ID: NCT05706519 Recruiting - Clinical trials for Coronary Heart Disease

Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine

OMIC-CARD
Start date: December 19, 2022
Phase:
Study type: Observational [Patient Registry]

The objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major cardiovascular disease will be identified. Finally, the modification of these predictions will be evaluated based on the genetic profiles. The main hypothesis holds that the integration of metabolomics, genomic and nutritional information will serve to personalize the approach to cardiovascular disease, both in prevention and treatment, and that these tools, in turn, will be valid enough to be applied systematically and efficiently in the IMPaCT cohort.

NCT ID: NCT05705310 Recruiting - Coronary Disease Clinical Trials

Self-management and Theory-based Rehabilitation Encouraging New Gateways to Healthy-Hearts

STRENGTH
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention is translate current behaviour change in to community cardiac rehabilitation programmes for people living beyond a heart attack. The main question it aims to answer is whether adding a lifestyle change programme promoted maintenance of physical activity changes will be maintained following a cardiac rehabilitation programme. The problem Guidelines recommend that coronary heart disease patients should be offered cardiac rehabilitation which includes exercise programmes, education, and ongoing support within both clinical and community settings. Cardiac rehabilitation programmes reduce the risk of death and illness, but it is likely that patients will stop exercising without enough support. New was to encourage coronary heart disease patients to stay active both during and after taking part in cardiac rehabilitation programmes are needed. The project Behaviour change techniques can encourage patients to stay active for longer. The aim of this project is to see whether behaviour change can encourage coronary heart disease patients taking part in community-based cardiac rehabilitation programmes to stay active for longer compared with patients receiving the standard cardiac rehabilitation programme. The benefits It is hoped that these methods will encourage more cardiac rehabilitation patients to stay physically active for longer and improve health. The results will provide more evidence on using behavioural change techniques in cardiac rehabilitation programmes and have the potential to benefit many patients with coronary heart disease throughout Northern Ireland and the rest of the United Kingdom.

NCT ID: NCT05701358 Recruiting - Clinical trials for Coronary Artery Disease

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

COMPLETE-2
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

NCT ID: NCT05700877 Recruiting - Clinical trials for Cardiovascular Diseases

Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes

STENO INTEN-CT
Start date: January 26, 2023
Phase: Phase 4
Study type: Interventional

The investigators intend to perform a landmark study to answer whether a combined CVD screening and treatment strategy is beneficial for patients with type 2 diabetes (T2DM) without known cardiovascular disease (CVD) The investigators aim to answer the following main research questions: Do screening detected high-risk patients benefit of intensified medical treatment? Is it safe to de-intensify medical treatment among patients with a screening detected low risk of CVD? Does a CVD screening and treatment program improve patient reported health status? Cardiovascular risk remains high in patients with T2DM but unevenly distributed. Our current risk stratification strategies are far from optimal leading to both under- and over-treatment of patients. In recent years, noninvasive imaging of subclinical coronary artery disease by cardiac CT has improved considerably. This allows for easily accessible evaluations of coronary atherosclerosis burden and composition - exceptionally strong imaging biomarkers of future cardiovascular disease. An increasing amount of data suggests that cardiac CT may permit better risk stratification in patients with T2DM. At the same time, the pharmaceutical treatment of T2DM has changed with several new and expensive drug classes, each individually documented to reduce the risk for new or recurrent cardiovascular events. Thus, these new drugs may improve outcome in high-risk patients, whereas they may be wasteful and only lead to side effects in low-risk patients. In the Inten-CT study, the investigators combine these two pivotal developments. The investigators intend to improve risk stratification of patients with T2DM by use of cardiac CT and, based on this knowledge, the investigators wish to investigate if upgraded medical treatment in the high-risk population is beneficial and if de-intensified treatment in the low-risk population is safe. As a secondary aim, the investigators wish to investigate if such a strategy improves patient reported health status. These aims are in agreement with one of the important health indicators from The Danish College of General Practitioners: "We find and treat the patients and let the healthy stay healthy". The investigators intend with this strategy to improve not only cardiovascular outcome among patients with T2DM, but also their quality of life. The Inten-CT study is an investigator-initiated open-label event-driven randomized controlled trial including patients with T2DM stratified according to screen detected coronary artery calcification. The investigators expect inclusion of 7300 patients in 2 years and a mean follow-up period of 5 years.