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Peripheral Arterial Disease clinical trials at UCSF
16 in progress, 7 open to new patients

  • Endothelial Function and Vein Graft Remodeling

    open to eligible people ages 22–89

    The purpose of this study is to better understand why some vein bypass grafts develop narrowing. Evidence suggests that there is a relationship between inflammatory markers in the blood and the narrowing that occurs in blood vessels. In this study, we will look at inflammatory markers in the blood and how well the vein graft functions.

    San Francisco, California and other locations

  • Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

    open to eligible people ages 18–85

    This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.

    San Francisco, California and other locations

  • International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

    open to eligible people ages 21 years and up

    The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction. B. Secondary Aims Major: To compare angina-related quality of life between groups. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups. Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III

    Fresno, California and other locations

  • Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

    open to eligible people ages 35 years and up

    This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

    San Francisco, California and other locations

  • Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study

    open to eligible people ages 40 years and up

    It has been argued that social relationships are important to health and well-being. This study will investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.

    San Francisco, California and other locations

  • THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

    open to all eligible people

    The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

    San Francisco, California

  • Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

    open to eligible people ages 40–90

    The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.

    San Francisco, California

  • Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates

    Sorry, currently not accepting new patients, but might later

    The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients prior to liver and lung transplantation. The current protocol for coronary artery disease assessment at UCSF before liver and lung transplantation involves screening with stress tests and/or coronary angiograms in patients with increased risk of coronary artery disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA accuracy.

    San Francisco, California

  • Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

    Sorry, in progress, not accepting new patients

    Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial is to test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study is to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study is to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care increases insulin secretion and insulin sensitivity.

    San Francisco, California and other locations

  • Decisional Quality for Patients With Coronary Artery Disease

    Sorry, accepting new patients by invitation only

    The objective of the DeQCAD study is to measure the quality of the decision-making process for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are making treatment decisions. In particular, this study is seeking to answer: a) How informed are patients about their treatment choices, b) are patients participating in the decision-making process as much as they would like to, and c) do the treatment decisions made match patients' preferences?

    San Francisco, California and other locations

  • Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

    Sorry, in progress, not accepting new patients

    To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries. Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

    San Francisco, California and other locations

  • Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

    Sorry, in progress, not accepting new patients

    This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia. The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.

    San Francisco, California

  • Mediators of Atherosclerosis in South Asians Living in America

    Sorry, accepting new patients by invitation only

    South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

    San Francisco, California and other locations

  • Multifactor Risk Reduction for Optimal Management of PAD

    Sorry, in progress, not accepting new patients

    Patients with peripheral arterial disease (PAD) experience significant functional limitations due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality resulting from untreated cardiovascular disease (CVD) risk factors and aggressive atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine the synergistic effect of a multifactor risk reduction on walking distance, blood flow and quality of life in 300 patients with PAD. Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T) Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We will also explore the association between FMVD and decreased oxidative stress (as measured by oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide, plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic GMP). Secondary hypotheses examine the association between reducing CVD risk factors, improved endothelial function, increased walking distance, improved quality of life and number of metabolic syndrome abnormalities in PAD patients. Significance. This study will contribute to evidence on the efficacy of multiple risk factor reduction on improving physical function and quality of life in the understudied, elderly PAD patient. This study will also provide preliminary evidence for the biological basis for the efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the progression of atherosclerosis.

  • PREDICT-PVI Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention

    Sorry, accepting new patients by invitation only

    The overall goal of this multicenter collaborative research study is to identify genetic, proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower extremity revascularization in patients with advanced peripheral artery disease (PAD).

    San Francisco, California and other locations

  • Prevention of Serious Adverse Events Following Angiography

    Sorry, in progress, not accepting new patients

    The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.

    San Francisco, California and other locations