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Coronary Artery Disease clinical trials

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NCT ID: NCT03805048 Not yet recruiting - Clinical trials for Coronary Artery Disease

PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG

PROCTOR
Start date: January 30, 2019
Phase: N/A
Study type: Interventional

Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.

NCT ID: NCT03803020 Not yet recruiting - Clinical trials for Coronary Artery Disease

The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion

Start date: January 2019
Phase:
Study type: Observational [Patient Registry]

Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.

NCT ID: NCT03800082 Not yet recruiting - Pain Clinical Trials

Development and Usability Testing of HEARTPA♀N

HEARTPA?N
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (HEARTPA♀N) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with cardiac pain. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop HEARTPA♀N. Funding was received from the Canadian Institutes of Health Research to develop the HEARTPA♀N architecture and conduct usability testing (Phase 2, current proposal) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).

NCT ID: NCT03797651 Not yet recruiting - Clinical trials for Coronary Artery Disease, Acute Coronary Syndrome

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.

NCT ID: NCT03793049 Not yet recruiting - Clinical trials for Coronary Artery Disease

Repeatability and Reproducibility of the CADence™System

SEQUEL
Start date: January 12, 2019
Phase:
Study type: Observational

This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.

NCT ID: NCT03788512 Not yet recruiting - Clinical trials for Coexistence of Cerebral and Coronary Atherosclerosis

Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry

CoCCA
Start date: December 30, 2018
Phase:
Study type: Observational [Patient Registry]

Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center observational registry of patients hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes in both cerebral and coronary arteries. This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.

NCT ID: NCT03788369 Not yet recruiting - Coronary Stenosis Clinical Trials

Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

HCR registry
Start date: January 15, 2019
Phase:
Study type: Observational

This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.

NCT ID: NCT03782688 Not yet recruiting - Clinical trials for Stable Coronary Artery Disease

Precise Percutaneous Coronary Intervention Plan (P3) Study

P3
Start date: December 17, 2018
Phase:
Study type: Observational [Patient Registry]

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

NCT ID: NCT03780192 Not yet recruiting - Clinical trials for Coronary Artery Disease

INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

insProvisional
Start date: February 15, 2019
Phase:
Study type: Observational

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

NCT ID: NCT03774394 Not yet recruiting - Clinical trials for Coronary Artery Disease (CAD)

Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus

Start date: January 2019
Phase: Phase 4
Study type: Interventional

Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease (CAD). However, despite its benefits, many patients still experience recurrent atherothrombotic events. The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism.