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Coronary Disease clinical trials

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NCT ID: NCT05504031 Not yet recruiting - Clinical trials for Coronary Artery Disease

Hybrid Revascularization Versus Coronary Artery Bypass Grafting

Start date: January 2025
Phase: N/A
Study type: Interventional

Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.

NCT ID: NCT05497466 Not yet recruiting - Clinical trials for Coronary Artery Disease

PUMCH Study Into Individualized Scanning for Coronary Artery Disease

COE
Start date: January 1, 2023
Phase:
Study type: Observational

Cardiac computed tomographic angiography (CCTA) is a non-invasive diagnostic imaging technique for visualization of the coronary arteries and thus, frequently used in the evaluation of coronary artery disease (CAD). CT technology is improving continuously, and various technological advances not only increase diagnostic accuracy, but also provide a substantial reduction in radiation dose and scan acquisition time. These modifications challenge optimal synchronization and timing of scan protocols in CM administration due to a shorter data acquisition window, hereby creating opportunities for injection strategies with a decrease in total amount of contrast media (CM). [4-6] Reducing the radiation dose of CT angiography and injected CM dose have become a routine need and trend in clinical practice. In addition to this, physical factors such as cardiac output and body weight are considered important factors with regard to variability in vascular enhancement. A standard 'one size fits all' protocol with a standard injected CM volume, independent of weight and length of the patient has proven to be outdated and precision medicine in the future should be based on individually tailored scan and CM injection protocols that are more scientific and involve various parameters such as individual tube voltage, patients weight and heart rate to benefit patients by reducing radiation exposure and CM dose while fulfilling the diagnostic purpose. Prospective studies focused on modifying both scan and injection parameters were completed in the Dutch (representing European) patient population with body weight varying between 40 and 130kg by Maastricht University Medical Center (MUMC) and have shown very promising results in Dutch population. In theory, these scan and injection protocols should be applicable to both average Dutch population (e.g. European population) and other heterogeneous patient populations, i.e. world-wide patient populations with any BMI category. However, so far, the effectiveness of this approach has not been deliberately discussed in the (on average) heavier North American population or the lighter Asian population. So, prior to promotion of the individually tailored CT scan protocols for global use, we need to obtain enough evidence in terms of the diagnostic confidence from those protocols in Chinese patients who could represent Asian population.

NCT ID: NCT05477940 Not yet recruiting - Clinical trials for Coronary Heart Disease

Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results.

NCT ID: NCT05431309 Not yet recruiting - Clinical trials for Cardiovascular Primary Prevention Strategy

Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease

RESPECT
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy, in reducing the future risk of CHD which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure, in a community population aged 40 to 69 years with cardiovascular risk factors but no history of cardiovascular disease.

NCT ID: NCT05392491 Not yet recruiting - Clinical trials for Coronary Artery Disease

Brazilian Coronary ARtery Disease

BARD
Start date: June 1, 2022
Phase:
Study type: Observational

Although coronary artery disease may have a stable chronic clinical course, it is known that this reality does not apply to atherosclerotic plaques, they can grow, complicate, stabilize and again start new cycles of growth/destabilization/stabilization or quiescence in the presence or absence of symptoms. While in obstructive coronary lesions there are well-founded guidelines based on multiple clinical studies, in relation to investigation and treatment; on the other hand, in non-obstructive lesions, there are no such guidelines. There are gaps in the knowledge about the prognostic implications of minor injuries and the occurrence of events. This study seeks precisely to fill these knowledge gaps. Of particular relevance are the large number of patients (approximately 10,000 patients) and the long clinical follow-up, that is, in five years.

NCT ID: NCT05369728 Not yet recruiting - Clinical trials for Coronary Artery Disease

Screening Of CoRonary ArTEry diSease

SOCRATES
Start date: May 2022
Phase: N/A
Study type: Interventional

This study is a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs functional tests, allowing the evaluation of the quality of life of these patients in relation to the health resources used. In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.

NCT ID: NCT05342961 Not yet recruiting - Clinical trials for Coronary Artery Disease

Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..

NCT ID: NCT05314140 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study

TOSCANA
Start date: June 1, 2022
Phase:
Study type: Observational

There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.

NCT ID: NCT05300178 Not yet recruiting - Clinical trials for Coronary Artery Disease

Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization

Start date: March 22, 2022
Phase:
Study type: Observational

CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia . If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results . Indications of this operation are more than 50% diameter stenosis of the left main coronary artery, more than 70% diameter stenosis in proximal left anterior descending artery (LAD), more than 70% diameter stenosis in three major coronary vessels, ventricular septal defect related to myocardial infarction , papillary muscle rupture , free wall rupture , ventricular pseudoaneurysm , life-threatening ventricular arrhythmias, and cardiogenic shock. Multiple methods have evolved to achieve the best outcome .The revascularization process depend on two main graft either artery or venous , each has its advantage and disadvantage according to their elasticity , ability to deliver an adequate flow and sustain high blood pressure. Our focus is on the different configuration used for the revascularization by using the artery grafts only due to the superiority of the artery graft in comparison to the venous according to the outcomes and not the feasibility of the technique .It is recommended to begin with internal thoracic artery then saphenous vein if both failed then multiple conduits will be used . Bilateral internal thoracic artery grafting can be an optimal option for coronary artery bypass grafting ,but it's the long-term outcome is still under study.There is no accepted configuration of the anastomosis to be used in the multiple conduits .

NCT ID: NCT05246722 Not yet recruiting - Clinical trials for Coronary Heart Disease

Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease (PHARM-ageing)

Start date: February 2022
Phase:
Study type: Observational [Patient Registry]

A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease