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Myocardial Ischemia clinical trials

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NCT ID: NCT01276808 Recruiting - Clinical trials for Coronary Artery Disease

Magnetic Navigation for Contrast and Radiation Reduction

MAGNA
Start date: October 2011
Phase: N/A
Study type: Interventional

Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and irradiation for patients undergoing percutaneous coronary intervention. The investigators aim to compare the use of the 2 techniques. Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by a clinical prediction rule). Study design: Prospective randomised controlled, single-blind trial Study population: Healthy human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the placement of the angioplasty wire with magnetic navigation and the other has the angioplasty wire placed by conventional technique. All other interventions will be performed as per routine practice. Main study parameters/endpoints: Primary endpoint The primary endpoint is the amount of contrast used. Secondary endpoints 1. Contrast needed to cross a lesion 2. procedural time 3. radiation exposure 4. Clinical complications at 1 and 12 months 5. procedural success Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The index procedure is performed as per normal routine and includes history and examination. A blood test will be taken once vascular access has been obtained. After the procedure a questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit with ECG will be planned for a year after the index procedure. No additional significant physical or psychological discomfort is expected with participation in the study.

NCT ID: NCT01276678 Recruiting - Clinical trials for Coronary Artery Disease

Multi-Analyte, Genetic, and Thrombogenic Markers of Atherosclerosis

MAGMA
Start date: June 2010
Phase: N/A
Study type: Observational

About 13 million people in the United States have coronary artery disease (CAD). It is the leading cause of death in both men and women. Coronary artery disease (CAD) occurs when the blood vessels that supply blood to the heart muscle (the coronary arteries) become hardened and narrowed. The arteries harden and narrow due to buildup of fatty and calcified material called plaque on their inner walls. The buildup of plaque is also called atherosclerosis. This is a process which starts early in life, but can be influenced by multiple factors. Several factors increase the risk of developing atherosclerosis. They include high blood pressure, smoking, diabetes, high cholesterol and being related to someone who had a heart attack or a stroke. The more risk factors you have, the greater the chance that you have severe atherosclerosis. Some of the risk factors cannot be modified, like age and family history of early heart disease. The influenceable factors include high blood pressure, high blood cholesterol, high blood sugar, cigarette smoking, overweight or obesity, and lack of physical activity. Nevertheless, there are patients without any above mentioned risk factors who develop atherosclerosis. In addition to that, there are also patients with several risk factors who do not develop severe coronary artery disease. According to research studies high blood levels of some substances in the blood (biochemical markers) as well as some genes in the DNA of our cells may be associated with an increased risk of developing CAD and faster progression of the disease. The purpose of this study is to find a correlation between certain blood markers and growth of the plaques, regardless of the presence of the classic risk factors for atherosclerosis. If we prove our hypothesis we will be one step closer to predicting the extent of atherosclerosis by performing certain blood tests.

NCT ID: NCT01268917 Recruiting - Clinical trials for Coronary Artery Disease

The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

Start date: March 2010
Phase: Phase 3
Study type: Interventional

Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.

NCT ID: NCT01267734 Recruiting - Clinical trials for Coronary Heart Disease

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen

HOST-ASSURE
Start date: June 2010
Phase: Phase 4
Study type: Interventional

Objectives 1. To compare the safety and long-term effectiveness of coronary stenting with the new platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in patients with coronary heart disease (CHD) 2. To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT, Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients 1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure (TLF) 2. Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT). Randomization will also be stratified per presence of DM. Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the procedure. Angiographical follow-up will be recommended to all participants at 13 months after the procedure. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary endpoint 1. Target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) up to 12 months for the stent arm 2. Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria at 1 month for the anti-platelet arm

NCT ID: NCT01267331 Recruiting - Clinical trials for Left Ventricular Dysfunction

Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery

Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.

NCT ID: NCT01266239 Recruiting - Clinical trials for Ischemic Heart Disease

Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion

J-REVERSE
Start date: July 2010
Phase: N/A
Study type: Interventional

In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

NCT ID: NCT01260558 Recruiting - Clinical trials for Coronary Heart Disease

Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography

PPS/PFS-OCT
Start date: December 2010
Phase: Phase 4
Study type: Interventional

The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.

NCT ID: NCT01257373 Recruiting - Clinical trials for Coronary Artery Disease

Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

Start date: April 2010
Phase: Phase 4
Study type: Observational

The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium(CoCr)-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.

NCT ID: NCT01257282 Recruiting - Clinical trials for Stable Angina Pectoris

Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)

PUMI
Start date: September 2007
Phase: N/A
Study type: Observational

This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial damage and its prognostic implication.

NCT ID: NCT01255267 Recruiting - Clinical trials for Acute Coronary Syndrome

The Correlation Between Genetic Polymorphism, Platelet Activity, Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients

Start date: n/a
Phase: N/A
Study type: Observational

In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness.