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Coronary Artery Disease clinical trials

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NCT ID: NCT01557855 Completed - Clinical trials for Coronary Artery Disease

Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease

REGISTRY-I
Start date: April 2012
Phase:
Study type: Observational

The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

NCT ID: NCT01557543 Terminated - Clinical trials for Coronary Artery Disease

Stem Cell Injection to Treat Heart Damage During Open Heart Surgery

Start date: February 29, 2012
Phase: Phase 1
Study type: Interventional

Background: - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage. Objectives: - To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. Eligibility: - Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. - Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery. - During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures. - After the surgery, participants will be monitored for complications from the stromal stem cells. - Participants will have heart function tests to see if the stromal stem cell treatments were effective....

NCT ID: NCT01557088 Completed - Clinical trials for Endothelial Dysfunction

Lp-PLA2 and Coronary Atherosclerosis in Humans

AIM 1 and II
Start date: February 2009
Phase: N/A
Study type: Interventional

The majority of the acute coronary events are caused by coronary artery segments with minimal luminal disease, but with potentially significant vascular wall inflammation and oxidative stress leading to plaque vulnerability. It has become apparent that an initial injury at the endothelial surface, is the primary site of the mechanisms involved and a role for vascular inflammation and the interaction with oxidative stress continues to emerge. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall inflammation that circulates in the blood bound to both low density (LDL) and high density (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and activity are an independent risk factor for cardiovascular events. Recent studies, demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction. However, the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary arteries, and the contribution of lipoprotein binding to the deleterious potential of Lp- PLA2 have not been elucidated. Our working hypothesis is that the endogenous local activation of the Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis and contributes to the mechanism of coronary endothelial dysfunction and the structural and mechanical properties reflecting plaque vulnerability. Thus, the current application will characterize prospectively the correlation between the functional, mechanical, and structural vascular wall properties, and the systemic as well as the coronary activity of the Lp-PLA2 pathway.

NCT ID: NCT01556022 Completed - Myocardial Ischemia Clinical Trials

Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

ATHENA
Start date: June 2012
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.

NCT ID: NCT01555658 Not yet recruiting - Clinical trials for Coronary Artery Disease

Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial

BILLION
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Background: Randomized trials show improved outcomes among acute coronary syndrome (ACS) patients treated with Bivalirudin1. Optimal antithrombotic treatment in patients undergoing percutaneous coronary intervention (PCI) is crucial to balance the risk of post-PCI bleeding versus ischemic complications2. Bivalirudin, a direct thrombin inhibitor has been extensively investigated as an intra-procedural antithrombotic therapy in patients with stable angina, Non ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation myocardial infarction (STEMI). Bivalirudin, when used with or without glycoprotein IIb/IIIa inhibitors (GPI) during PCI has been found to be superior to Unfractionated heparin (UFH) with or without GPI in reducing 30-day bleeding complications without significant increase in the rate of ischemic events3-5. Moreover,after otherwise successful PCI,an increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients6. Recent studies have focused their attention onthe reduction of infarct size and the incidence of periprocedural (type IVa) myocardial infarction (PMI)after elective PCI7-8. Therefore, we will perform a single-center, prospective and randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel,with anatomically complex lesion. Objective: to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with coronary artery disease (CAD), after stent implantation in coronary long lesions, to avoid periprocedural myocardial necrosis. Setting: Single-center, spontaneous, prospective, randomized 1:1 study of Bivalirudin infusion vs UFH in the setting of CAD, after PCI with stenting incoronary long lesions. Comparison: Bivalirudin vs UFH, in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel, with anatomically complex lesion. Population:Patients with diffuse CAD undergoing percutaneous treatment on a native coronary vessel with planned implantation stents in overlapping with a total stent length >33 mm for long coronary lesions in vessels with a reference vessel diameter 2.25-4.0 mm. Assessment Following the procedure, blood samples for CK, CK-MB and Troponin will be collected at 6,12 and 24 h post PCI. CK-MB values will be considered abnormal if they will elevate above the upper limit of normal (ULN). This is set at 6 mg/L by our local laboratory. If the first blood sample showed a CK-MB level ≥18 mg/L (≥3 times upper normal limit), a second blood sample would be drawn every 8 h later until a downward trend will be observed. For patients with two or more blood samples drawn, the peak CK-MB level will be used for analysis. End-points: The primary end-point of this study will be the incidence of periprocedural myonecrosis that was defined as a peak post-procedural CK-MB elevation > 1 time the upper limit of normal (ULN) alone or associated with chest pain or ST-segment or T-wave abnormalities, in patients undergoing non-urgent PCI. Secondary end-points will be the rate of MACCE (major adverse cerebro-cardiovascular events, ie the composite of death, myocardial infarction [defined according to the Academic Research Consortium statement], target vessel revascularization or stroke), the rate of major bleedings (Bleeding Academic Consortium [BARC] 3-5), minor bleedings (BARC 2), and the rate of NACE (net adverse clinical events, ie the composite of MACCE and major bleedings) at 30 days, 6 and 12 month follow-up. Adverse events will be determined by telephone interview and/or medical record review. Clinical follow-up: telephone-based interviews and office-based direct visits will be performed at 1, 6 and 12 months, respectively, for end-point adjudication. Sample size and statistical analysis: Given an expected rate of abnormal post-procedural peak CK-MB > 1 x ULM of 48% (based on results of the INSTANT trial) for the control group and 29% for the experimental group (thus a 40% relative risk reduction), aiming for a 0.05 alpha and 0.80 power, a total of 204 patients will need to be enrolled (102 patients per group).

NCT ID: NCT01554800 Completed - Clinical trials for Coronary Artery Disease

Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.

NCT ID: NCT01553526 Active, not recruiting - Clinical trials for Coronary Artery Disease

BIOFLOW-III All-comers Orsiro Safety and Performance Registry

BIOFLOW-III
Start date: August 2011
Phase: N/A
Study type: Observational

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT01553513 Not yet recruiting - Clinical trials for Coronary Artery Disease

PET/CT for the Quantification of Atherosclerotic Plaque Inflammation

QAEK
Start date: June 2012
Phase: N/A
Study type: Observational

This is a single-centre prospective trial with 140 patients employing [18F]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance motion correction and image fusion algorithms to create motion frozen displays and quantify FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree. Four groups of patients, two with stable coronary artery disease and two with acute coronary syndrome will be compared and the results of FDG PET/CT will be correlated to results of invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk profile and serum markers of inflammation. The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques shows a positive correlation with inflammatory activity in coronary plaques and markers of plaque vulnerability as well as the risk profile of the patients and serum markers of inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect high risk patients and provide an important means for risk stratification and optimization of patient management.

NCT ID: NCT01552889 Completed - Depression Clinical Trials

Depression Outpatient Cardiology Screening Study

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

This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.

NCT ID: NCT01552161 Completed - Asthma Clinical Trials

Prevalence of Allergic Diseases and Atopy in Subjects With Coronary Artery Disease

Start date: April 2010
Phase: N/A
Study type: Observational

The purpose of this study is to estimate the prevalence of allergic diseases and atopy among patients with angiographically confirmed coronary artery disease as well as to assess levels of serum allergic inflammation markers in this population.