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Vascular Disease clinical trials

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NCT ID: NCT00633659 Completed - Vascular Disease Clinical Trials

Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia

Start date: September 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.

NCT ID: NCT00496938 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN

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

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT00489320 Completed - Clinical trials for Cardiovascular Diseases

An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

DESCOVER
Start date: December 2004
Phase: N/A
Study type: Observational

The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

NCT ID: NCT00484861 Completed - Clinical trials for Cardiovascular Diseases

Effect of Diet on Vascular Disease in Pre-Menopausal Women

Start date: June 7, 2007
Phase:
Study type: Observational

African Americans have a higher prevalence of vascular disease than Caucasians. Vascular disease can lead to heart attacks, strokes and even amputations. Insulin, a hormone which is secreted by the pancreas, affects not only glucose and fat metabolism but also vascular disease. Impairment of insulin s ability to remove glucose from the circulation is known as insulin resistance. To overcome insulin resistance the pancreas secretes extra insulin. These high levels of insulin affect circulating triglyceride levels by both promoting production of triglyceride by the liver and interfering with clearance of triglyceride from the circulation. Triglyceride in turn contributes to the development of vascular disease by causing both inflammation and hypercoagulability. Surprisingly African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians but have lower triglyceride levels. Because of the high rate of vascular diseases in African Americans, our aim is to determine if the adverse effects of triglyceride occur at a lower level in African Americans than Caucasians. To achieve this goal we will determine if there are differences in the effect of a meal on triglyceride levels and vascular function in a representative cohort of African American and Caucasian women. For this study we will enroll 96 women (48 African American and 48 Caucasian women). We are recruiting women because ethnic differences in triglyceride are even greater in women than men. We are enrolling women between the ages of 18 and 65 years. The study will involve several outpatient visits to the NIH Clinical Center. The first visit will be a screening to determine eligibility. At the second visit a test to measure insulin resistance will be performed. This test is called a frequently sampled intravenous glucose tolerance test. The third visit will be for the test meal. Before and at 2, 4 and 6 hours after the meal, blood will be drawn and vascular function measured. Vascular function is determined by taking blood pressure and then measuring blood flow in the arm with ultrasound. It is possible that individual differences in diet could affect the results of the vascular study on the day of the test meal. Therefore for 7 days prior to the test meal, the NIH Clinical Center will provide to each participant all their meals in the form of either trays or meals in a box. These meals will be consistent with the typical American diet and be 33% fat, 15% protein and 52% carbohydrate. In designing these meals, the dietician will take into account individual food preferences. This study is being performed in collaboration with the Harvard School of Public Health, the University of Texas Southwestern Medical Center and Indiana University. Therefore some blood drawn during Visits 2 and 3 will be sent coded, without personal identifiers, to each institution for analyses. ...

NCT ID: NCT00341562 Completed - Vascular Disease Clinical Trials

Genomics of In-Stent Restenosis

Start date: September 2005
Phase: N/A
Study type: Observational

This study, conducted in Argentina at the Hospital Espa ol de la Plata and the Hospital Franc s de Buenos Aires, in collaboration with the NHLBI, will investigate possible genetic factors that lead to in-stent restenosis. A stent is a wire mesh tube that is surgically placed to open a blocked artery. The stent stays in the artery permanently, holding it open to improve blood flow. In the case of blocked coronary arteries, the stent improves blood flow to the heart muscle, relieving symptoms such as chest pain and shortness of breath. Sometimes re-growth of tissue within a stent, called in-stent restenosis, leads to narrowing of the artery, decreased blood flow, and a recurrence of symptoms. Genetic analysis may allow the identification of patient that may be at increased risk for in-stent restenosis and lead to methods of prevention and treatment. Patients 18 years of age and older who are undergoing coronary endarterectomy (surgery to remove plaque from an artery) to treat in-stent restenosis at the Hospital Espa ol de la Plata and the Hospital Franc s de Buenos Aires may be eligible for this study. Participants will have a blood sample drawn and undergo coronary endarterectomy. Tissue removed from the patient's artery or the stent during surgery will be analyzed for gene expression profiling and genotyping. The results will be studied along with information about the patients' medical history.

NCT ID: NCT00334724 Withdrawn - Hypertension Clinical Trials

Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study

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

The purpose of this study is to determine whether blood pressure control by home blood pressure monitoring exerts beneficial cardioprotective effects rather than by clinic blood pressure monitoring in elderly patients.

NCT ID: NCT00299884 Completed - Dyslipidemia Clinical Trials

Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy

Start date: January 2005
Phase: Phase 4
Study type: Observational

The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

NCT ID: NCT00293748 Completed - Vascular Disease Clinical Trials

Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease

Start date: February 13, 2006
Phase: N/A
Study type: Observational

This study will determine if the drug Atorvastatin (Lipitor) changes the genetic material found in blood cells of people with vascular (blood vessel) disease. Vascular diseases affect the blood flow in the body and can lead to a heart attack or stroke. Information gained from this study could be used to develop a more reliable blood test that predicts the risk of heart attack or stroke. People 21 and older who have two or more risk factors for developing vascular disease are eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, ultrasound of the carotid (neck) arteries, blood tests, and check of blood pressure and heart rate. Participants are randomly assigned to one of four treatment groups. Three groups receive Lipitor in a dose of either 10, 20 or 40 milligrams; the fourth group receives a placebo. All take the study drug for 3 months. In addition, they undergo the following tests and procedures: Study Phase I (Months 2-4) Participants in all groups are seen once a month at the NIH Clinical Center for blood tests and monitoring of drug side effects. Study Phase 2 (Months 5-10) - Placebo group: Participants are given 40 mg of Lipitor for 3 months (months 5-7) and seen by a physician once a month during that time. Blood is drawn at the 7-month visit and then participants are referred back to their physicians. During months 8, 9 and 10, participants are called once a month to check on their health. Participation ends after the tenth month. - Lipitor group: Participants are referred back to their physicians for months 5 and 6 and are called once a month. During month 7, they return to the clinic for a follow-up evaluation and blood test. Participation ends after the seventh month.

NCT ID: NCT00236210 Completed - Obesity Clinical Trials

A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program

Start date: August 2004
Phase: N/A
Study type: Interventional

VIP is a demonstration project with a goal to decrease modifiable risk factors for those with a higher risk of having a vascular event such as a heart attack or stroke or of developing vascular disease. Introduced as a study, VIP compares whether there is a significant reduction of modifiable vascular risk factors among patients who are involved in a personalized directed program versus those being provided standard care by their physician. Health care providers work collaboratively with the 'VIP Team' to improve the participants' vascular health.

NCT ID: NCT00180479 Completed - Clinical trials for Coronary Artery Disease

SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Start date: June 2005
Phase: Phase 3
Study type: Interventional

This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System 2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS 3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS 4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS 5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.