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Myocardial Ischemia clinical trials

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NCT ID: NCT00698607 Active, not recruiting - Clinical trials for Coronary Artery Disease

Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing

EXCELLENT
Start date: June 2008
Phase: Phase 4
Study type: Interventional

Objectives 1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis. 2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy. Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm) Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea. Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary Endpoint - In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. - Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy Secondary Endpoint - All Death - Cardiac death - Myocardial infarction - Target vessel revascularization (TVR) (all and ischemia-driven) - Target lesion revascularization (TLR) (all and ischemia-driven) - Stent thrombosis - Acute success (device, lesion, and procedure) - Bleeding - Cerebrovascular accident - In-stent LL at 9 months - Angiographic pattern of restenosis at 9-month angiographic follow-up - In-stent and in-segment % diameter stenosis (%DS) at 9 months - In-stent % volume obstruction (%VO) at 9 months - Incomplete stent apposition post index procedure - Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

NCT ID: NCT00679419 Active, not recruiting - Clinical trials for Coronary Artery Disease

Coronary Artery Disease and Renal Failure Registry

CAD-REF
Start date: December 2007
Phase: N/A
Study type: Observational

It is the aim of the multi-centric and prospective registry to analyze in patients with CAD the impact of different grades of renal failure on the outcome and course of the patients and to correlate these with clinical variables. In particular, the registry has the following objectives: - prospective consecutive assessment of all patients with coronary artery disease and renal failure in the participating hospitals of the registry - evaluation of the outcome and course of patients with regard to their different stages of renal failure at baseline - analysis of the impact of different therapeutic strategies on acute and long-term outcomes - identification of clinical risk factors, novel biomarkers and genetic markers for an unfavorable long-term outcome

NCT ID: NCT00661206 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

ISAR-SAFE
Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

NCT ID: NCT00651521 Active, not recruiting - Clinical trials for Coronary Artery Disease

Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients

Start date: April 2009
Phase:
Study type: Observational

The prevalence and mortality rate of cardiovascular disease (CVD) in chronic kidney disease (CKD) patients is high. The prevalence of coronary artery disease (CAD) in CKD population ranges from 38 to 65%, with an average of 3.3 coronary lesions per person. The relative risk for death from myocardial infarction and CAD is 1.18 in CKD patients with GFR < 60 ml/min. Because of this high prevalence of CAD and its high mortality, reducing and preventing CAD risk factors is crucial in the clinical management of CKD patients. Low glomerular filtration rate (GFR) constitutes an important independent risk factor for CAD. Several pathogenic factors play role in the genesis of cardiovascular dysfunction in chronic kidney disease. Increased traditional CAD risk factor, endothelial dysfunction, sympathetic hyperactivity, renin-angiotensin system activation, increased glycosylated end products, all contribute to the characteristic medial calcification of cardiovascular disease in CKD patients. Hypertension, fluid overloading and anemia further aggravated the cardiac loading, leading to myocardial hypertrophy with chamber dilatation, heart failure and death. The mortality rate of CAD in CKD patients is extremely high. The NHANES II (National Health and Nutritional Evaluation Survey) found an increased of mortality rate> 51%, when the GFR decreased from > 90 to < 70 ml/min. The 1-year mortality rate in different CKD stage were 0.7% (normal renal function patients), 2.0% (patients with proteinuria), 3.5% (overt proteinuric patients) and 12.1% (dialysis patients), respectively. However, the clinical feature and outcome of CAD in different stage of CKD remains unclear. We conducted a retrospective cohort study involving all patients admitted for coronary angiography from 1992 to 2004. The patients were categorized into five stages of CAD to compare the risk factor, clinical feature and outcome. Determination of this relationship can help to establish factors for early detection of CAD in CKD patients and also prognostic factor to improve outcome of these patients.

NCT ID: NCT00627029 Active, not recruiting - Cancer Clinical Trials

Evaluation of Programs of Coordinated Care and Disease Management

Coca
Start date: September 2000
Phase: N/A
Study type: Interventional

This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs. In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.

NCT ID: NCT00626964 Active, not recruiting - Hypertension Clinical Trials

Prevention of Coronary Heart Disease in Morbidly Obese Patients

SphCor
Start date: February 2008
Phase:
Study type: Observational

The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

NCT ID: NCT00590200 Active, not recruiting - Clinical trials for Cardiovascular Diseases

GeneBank at the Cleveland Clinic: Molecular Determinants of Coronary Artery Disease

GATC
Start date: January 2001
Phase:
Study type: Observational

This proposal delineates a research plan to collect blood from patients undergoing heart catheterization or who have had a heart catheterization within one year and are coming in for outpatient appointments, or who have scheduled cardiac CT scans at the Cleveland Clinic over a five-year period for the purpose of establishing a gene bank registry. In addition, the University of North Carolina at Chapel Hill will enroll 1,000 non-Caucasian patients and MetroHealth Medical center in Cleveland will enroll 1,000 non-Caucasian patients. The blood collected will be processed to create a repository of DNA, lymphoblastoid cell line immortalization on selected patient populations, plasma and serum. The DNA will be amplified in certain patient populations to preserve the quantity. Along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data (available for about 55% of patients at the present time), and laboratory data will be collected. A short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. All the clinical data gathered will be compiled in GATC heart center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

NCT ID: NCT00489801 Active, not recruiting - Clinical trials for Coronary Heart Disease

Trial Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial

HOME-BASE
Start date: January 2007
Phase: N/A
Study type: Interventional

Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.

NCT ID: NCT00457236 Active, not recruiting - Clinical trials for Coronary Artery Disease

Effect of Clopidogrel Loading and Risk of PCI

EXCELSIOR
Start date: March 2003
Phase: N/A
Study type: Observational

This study is a prospective, single-center evaluation of the impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI.

NCT ID: NCT00410241 Active, not recruiting - Healthy Volunteers Clinical Trials

ClinSeq: A Large-Scale Medical Sequencing Clinical Research Pilot Study

Start date: January 5, 2007
Phase:
Study type: Observational

This study will examine genome sequencing in clinical research. Genome sequencing is a process in which researchers analyze (or sequence) part or all of the genome from a single person. The human genome is the material in cells that includes thousands of genes. Gene changes that cause or contribute to disease can be passed on from one generation to the next. This study first focuses on heart disease. Later, researchers hope to study other conditions and genes, with the eventual goal of sequencing most or all of participants genes. Participants ages 45 to 65 years of age and who do not smoke, may be eligible for this study. Patients will come to the NIH Clinical Research Center for an initial study to last about half a day. They will donate a blood sample and complete a short survey. Then they will meet the genetic counselor to learn more about genome sequencing. Those who join the study will undergo the following procedures and evaluations: - Family history and medical history. - Measurement of height and blood pressure. - Noninvasive heart tests, including electrocardiogram and echocardiogram. - Drawing of about 3 ounces of blood (5 to 6 tablespoons); part of the blood sample will be used for research and another part for clinical testing. - Multidetector computed tomography (CT), a test to measure coronary artery calcification, that is, condition of inflexibility. Each patient will receive a letter with results of the clinical laboratory values and evaluations. There will be recommendations for follow-up with the patient s doctors. Risks in this study include exposure to radiation from the CT test. The radiation amount used is about the same that a person normally receives from natural sources, such as from the sun, outer space, and radioactive materials found naturally in the earth s air and soil. Another slight risk involves reactions to a contrast agent that may be used in the echocardiogram. Side effects can be headache, nausea or vomiting, a warm sensation, and dizziness. With the samples that patients provide, researchers will start by sequencing about 400 genes related to heart disease. Analysis will take months to complete. Genome sequencing is difficult to do, and researchers have much to learn about the genes they sequence and the gene changes they find. If the researchers find gene changes that are important to the health of a participant, they will contact that participant and give him/her the choice of learning such results. This study may or may not have a direct benefit for participants. Patients would get free clinical testing for cholesterol, diabetes, and other conditions, as well as information about gene changes. Knowledge gained will benefit people in the future as researchers learn about the relationship between gene changes and health.