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Coronary Disease clinical trials

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NCT ID: NCT00448461 Completed - Clinical trials for Coronary Artery Disease

Antithrombotic Regimens and Outcome

ARNO
Start date: March 2007
Phase: Phase 4
Study type: Interventional

PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine in elective percutaneous coronary interventions (PCI) Design: Prospective, randomized, controlled trial Hypothesis: Bivalirudin is superior to UFH + protamine for the improvement of outcomes in patients undergoing elective PCI Key Inclusion Criteria: Patients older than 18 years of age to undergo PCI Clopidogrel loading > 6 hrs prior to PCI according to the PCI guidelines Informed, written consent Key Exclusion Criteria: ST-elevation myocardial infarction within the prior 48 hours Active bleeding, bleeding diathesis, recent surgery Severe renal failure Chronic coronary artery occlusion to be treated Primary endpoint: Inhospital major bleeding Secondary endpoints: 1. Composite rate of death, myocardial infarction (MI) or target vessel revascularization (TVR) inhospital, and at 6 months 2. Composite rate of inhospital death, MI or TVR and major bleeding 3. Major and minor bleedings 4. Total vascular complications 5. Post-procedure renal failure Randomization: Bivalirudin versus unfractioned heparin followed by protamine at the end of the PCI procedure Sample size: Assumed incidence of inhospital major bleeding of 6% in UFH + protamine and of 2% in bivalirudin group; for a power of 80% and a level of 0.05 for each group 425 patients are needed. An interim analysis will be performed after the enrolment of 425 (50%) patients. Follow-up: Inhospital, and 6-month clinical follow-up (out-patient clinic or by phone)

NCT ID: NCT00447148 Completed - Clinical trials for Coronary Artery Disease

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison

3-DCA
Start date: October 2006
Phase: Phase 4
Study type: Interventional

Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.

NCT ID: NCT00445835 Completed - Clinical trials for Coronary Artery Disease

Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients

AMERICA
Start date: September 2007
Phase: N/A
Study type: Interventional

Coronary artery disease is the first cause of death related to atherothrombosis.

NCT ID: NCT00442897 Completed - Clinical trials for Hypercholesterolemia

Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

Start date: September 2006
Phase: Phase 4
Study type: Interventional

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

NCT ID: NCT00442806 Completed - Clinical trials for Myocardial Infarction

Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.

NCT ID: NCT00439855 Completed - Clinical trials for Coronary Artery Disease

Enoxaparin Versus Unfractionated Heparin in PCI

Start date: September 2003
Phase: Phase 4
Study type: Interventional

Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI

NCT ID: NCT00438919 Completed - Clinical trials for Coronary Artery Disease

A Multi-center Post-Market Surveillance Registry

E-SELECT
Start date: May 2006
Phase: Phase 4
Study type: Interventional

This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECTâ„¢ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.

NCT ID: NCT00437138 Completed - Clinical trials for Coronary Heart Disease

Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease

Start date: April 2006
Phase: Phase 0
Study type: Interventional

Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. We hypothesise that these adverse effects are mediated by combustion derived air pollutants and that even a brief exposure will effect heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at levels encountered in urban road traffic on heart and blood vessel function in patients with stable coronary heart disease.

NCT ID: NCT00433784 Completed - Clinical trials for Coronary Artery Disease

H2 Haplotype and CYP3As Polymorphisms and the Antiplatelet Response to Clopidogrel

Start date: September 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study was to assess whether interpatient variability in the platelet response to clopidogrel is partly due to polymorphisms of the hepatic cytochrome P450 (CYP450)3A and of the clopidogrel-P2Y12 receptor genes.

NCT ID: NCT00430989 Completed - Clinical trials for Coronary Artery Disease

The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial

Start date: April 2007
Phase: Phase 4
Study type: Interventional

To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.