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Coronary Disease clinical trials

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NCT ID: NCT01869452 Completed - Heart Failure Clinical Trials

Platform Therapeutic Education in Heart Failure and Coronary Disease

METISCARDIO
Start date: May 2010
Phase: N/A
Study type: Interventional

A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.

NCT ID: NCT01863147 Completed - Clinical trials for Coronary Artery Disease

Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong predictor of cardiovascular events and all-cause mortality . Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .

NCT ID: NCT01861860 Completed - Diabetes Clinical Trials

OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA

OPERA
Start date: October 2012
Phase: N/A
Study type: Interventional

Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization (AVIO) study was performed with (medical device's type )Promus stent, results are promising, but the study was not designed for clinical endpoint. There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were recently proposed for complex lesions, but these criteria also have some issues and the complexity make their routine use challenging. We performed a pilot study for long complex lesion analysis using IVUS, in order to define easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The new criteria (OPERA) are an adaptation of the MUSIC criteria. OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the study. Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element stent deployment? Study design This study will consist to prospectively include consecutive patients with>28mm taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients from the OTELLO study, with the same inclusion criteria, will composed the control group . Population will be matched using the propensity score. 20 to 30 French centers involved in OTELLO study will be contacted for participating in OPERA. Hypothesis: Long lesion percutaneous coronary intervention(PCI) have specific characteristics like Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA criteria have better outcomes than without IVUS Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm implantation Secondary endpoint 1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria 2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI 3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric study propensity score matched analysis matched for comparison to OTELLO study. (Same inclusion criteria as OTELLO) Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions. Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months telephone contact Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery, According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours

NCT ID: NCT01856504 Completed - Clinical trials for Coronary Artery Disease

Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY

VICTORY
Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.

NCT ID: NCT01856088 Completed - Clinical trials for Coronary Artery Disease

DESTINY TRIAL (Inspiron x Biomatrix)

Start date: May 2013
Phase: Phase 4
Study type: Interventional

The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.

NCT ID: NCT01853592 Completed - Clinical trials for Coronary Arteriosclerosis

Gadofosveset Trisodium for Heart Imaging Studies

Start date: March 8, 2013
Phase:
Study type: Observational

Background: - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans. Objectives: - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans. Eligibility: - Healthy volunteers between 18 and 45 years of age. Design: - Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions. - Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study. - Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan. - An additional blood sample will be collected within 1 week of the second MRI scan.

NCT ID: NCT01853527 Completed - Myocardial Ischemia Clinical Trials

Myocardial Ischemia in Non-obstructive Coronary Artery Disease

MicroCAD
Start date: April 2013
Phase:
Study type: Observational

The aim of the study is to assess presence of myocardial ischemia by contrast stress echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD) by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of myocardial ischemia in such patients.

NCT ID: NCT01853410 Completed - Clinical trials for Coronary Artery Disease

Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease

PERCCAD
Start date: July 2013
Phase: Phase 1
Study type: Interventional

The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada) on coronary blood flow in order to assess its potential role as a therapeutic modality for the treatment of symptomatic coronary artery disease (CAD). This will occur in patients already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part of their usual medical care. Further, the investigators will also assess the overall effect on blood flow in the body using non-invasive techniques. The primary objective of the PERCCAD study is to assess the effect of the gekoTM device on coronary blood flow in patients with symptomatic CAD who are undergoing invasive angiographic assessment and management with PCI. This evaluation of the gekoTM device is to be performed at the time of the patient's already planned invasive assessment and management so that invasive data can be collected without exposing the patient to risks other than those already associated with their planned procedure and usual clinical care. The secondary objective of the study is to assess the effect of muscle stimulation with the gekoTM device on endothelial function and peripheral blood flow measured via non-invasive techniques.

NCT ID: NCT01852214 Completed - Clinical trials for Coronary Artery Disease

Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes

Start date: February 2013
Phase: N/A
Study type: Interventional

Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic events. This may be in part attributed to the fact that these patients have reduced response to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel, used for secondary prevention of ischemic events. Prasugrel and ticagrelor are recently approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent antiplatelet effects. Head-to-head comparisons between the two drugs are lacking.

NCT ID: NCT01852175 Completed - Clinical trials for Coronary Artery Disease

Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

Start date: January 2012
Phase: N/A
Study type: Interventional

Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel and are associated with an improved net clinical benefit. However, to date there are limited head-to-head comparisons of these two new agents.