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Coronary Disease clinical trials

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NCT ID: NCT00323895 Completed - Clinical trials for Coronary Artery Disease

The Intra-Drug Eluting Stent (DES) Restenosis Study

CRISTAL
Start date: March 2006
Phase: Phase 4
Study type: Interventional

A Prospective, Randomized, Multi-Center Comparison of the Cypher Selectâ„¢ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

NCT ID: NCT00322569 Completed - Coronary Disease Clinical Trials

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)

Start date: July 2006
Phase: Phase 3
Study type: Interventional

To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions <25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.

NCT ID: NCT00321139 Completed - Clinical trials for Coronary Artery Disease

Assessment of Translesional Markers and Metabolomics

Start date: April 2006
Phase: Phase 4
Study type: Observational

Blockages in the blood vessels of the heart are the main cause of chest pain, heart attacks, and sudden death. A cardiac catheterization, or injecting x-ray dye into the blood vessels of the heart and taking pictures, is currently the best way of assessing these blockages. This procedure, however, does not allow us to know what is happening inside the blockages. Some blockages have a higher risk of "rupturing" and completely blocking of the blood vessel while others are at low risk for doing this. Blood levels of different substances produced by the body have been shown to be associated with a higher risk of having chest pain, a heart attack, or sudden death. There is also evidence from studies in animals and tissues taken from humans during surgery that some of these substances are made in the blockages themselves. We would like to investigate whether a number of these substances are made in the blockages and released into the bloodstream. We will do this by taking one tablespoon samples of blood upstream and downstream of the blockages in the blood vessels of the heart. The samples will be obtained by using a very thin catheter, or plastic tubing, that is about 1/3 the size of the blood vessels of the heart. We will take samples from the tightest blockage found as well as another, less tight, blockage and compare the two. We will also sample blood from the tightest blockage after it is opened by doing an angioplasty. Finally, we will also take pictures of the blockages studied using a very small ultrasound camera inserted into the blood vessel. We will compare the levels of the substances measured with the features we see on the pictures. We hope to learn if some or all of the substances measured can identify which blockages are more at risk for rupturing and causing heart attacks and sudden death. All patients who are entered into this study will already be having an angioplasty done. The procedures needed for the study (sampling of blood and taking pictures with an ultrasound) are already often, though not always, used in patients undergoing an angioplasty.

NCT ID: NCT00321009 Completed - Clinical trials for Coronary Artery Disease

LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Start date: March 2000
Phase: N/A
Study type: Interventional

To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.

NCT ID: NCT00319566 Completed - Clinical trials for Coronary Heart Disease

Heart and Estrogen-Progestin Replacement Study (HERS)

Start date: July 1992
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

NCT ID: NCT00319449 Completed - Clinical trials for Hypercholesterolemia

Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

Start date: September 2005
Phase: Phase 4
Study type: Interventional

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

NCT ID: NCT00317395 Completed - Coronary Disease Clinical Trials

Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome

SEPIA-ACS1
Start date: June 2006
Phase: Phase 2
Study type: Interventional

Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy. Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).

NCT ID: NCT00316368 Completed - Coronary Disease Clinical Trials

A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft

Start date: October 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement. Primary Hypothesis: - Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with standard atrio-right ventricular pacing. Secondary Hypothesis: - Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium pacing.

NCT ID: NCT00314275 Completed - Clinical trials for Coronary Artery Disease

The ENDEAVOR Pharmacokinetic (PK) Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System

ENDEAVOR PK
Start date: January 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter.

NCT ID: NCT00313339 Completed - Clinical trials for Coronary Artery Disease

Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction

AMR-1
Start date: March 2006
Phase: Phase 1
Study type: Interventional

Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death. There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement. The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels. The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.