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Cardiovascular Disease clinical trials

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NCT ID: NCT03785431 Recruiting - Clinical trials for Cardiovascular Disease

Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study

FANTOM STEMI
Start date: June 6, 2017
Phase: N/A
Study type: Interventional

The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and patient related measures in STEMI patient who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main coronary arteries will be included in the trial and prospectively observed. The study will comprise 20 patients, who will undergo additional evaluation with optical coherence tomography (OCT) and near-infrared spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36 months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18 mm in length.

NCT ID: NCT03625349 Recruiting - Aging Clinical Trials

Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation

Start date: September 1, 2015
Phase:
Study type: Observational

Brief Summary: Current U.S. Veteran demographics reveal an aging population with significant cardiovascular dysfunction. This ultimately manifests as mobility limitation, inactivity, and a subsequent worsening of cardiovascular disease (CVD) that often leads to death. However, despite this clear negative cycle of events, there is not a single clinically accepted, and therefore routinely utilized, method of assessing vascular health. As nitric oxide (NO) is anti-atherogenic and cardioprotective, identifying an in vivo bioassay of NO bioavailability has significant worth in this arena. Fueled predominantly by the VA Merit Award prior to this renewal application, single passive leg movement (sPLM) and the subsequent blood flow increase, measured non-invasively by ultrasound Doppler in the common femoral artery, is emerging as a method by which vascular endothelial function and therefore NO bioavailability can be determined. However, although this work has yielded an initial characterization of sPLM and established this method to be a novel, valid, and a clinically relevant approach to determine vascular health, further understanding of the sPLM response with advancing age and, ultimately, its implementation and assessment in both rehabilitation and clinical arenas is still necessary. With the growing interest in personalized medicine, the development of tools, such as sPLM, that allow individualized assessments to guide the physician, the patient, and the rehabilitative team, are essential. Therefore, two specific aims are proposed that will address the Central Hypothesis that the sPLM paradigm provides a clinically meaningful assessment of endothelial function. First, cardiac rehabilitation will be assessed by sPLM in the elderly, and, coupled with studies in the young, will elucidate the predominant pathways responsible for the change in endothelial function with aging and rehabilitation. Second, the CVD diagnostic value of the sPLM assessment of endothelial function will be evaluated relative to classic measures and markers of subclinical disease in order accelerate the inclusion of endothelial dysfunction as a CVD risk factor. The proposed studies aim to catalyze the transition of the assessment of endothelial function by sPLM from research to clinical practice.

NCT ID: NCT03414190 Recruiting - Clinical trials for Cardiovascular Disease

Impact of Text Messages to Promote Secondary Prevention After Acute Coronary Syndrome

IMPACS
Start date: November 29, 2017
Phase: N/A
Study type: Interventional

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.

NCT ID: NCT03372733 Recruiting - Clinical trials for Cardiovascular Disease

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

Start date: July 31, 2018
Phase: Phase 2
Study type: Interventional

Background: Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that this oil is good for heart health. Researchers want to find out more about these potential benefits. Objective: To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism. Eligibility: Healthy adults at least 18 years old with no known history of cardiovascular disease. Subjects not allergic to fish oil and fish products Females that are not pregnant and are not planning a pregnancy during the length of the study Design: Participants will be screened with questions about their health, medical history, and medicines they take. Participants will have 4 visits over 24 weeks. The visits may include: - Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw. - Vital signs (blood pressure, heart rate, and temperature) taken - Body mass index measured - Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant s arteries will be measured by reading blood pressure in the arms and legs and monitoring the heart. - Optional stool samples - Pregnancy test - A short review of participants physical activity and diet - A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day. Participants will keep a food and exercise journal Compensation will be provided to subjects that complete the study Check your eligibility for this study by clicking here: https://www.surveymonkey.com/r/DietaryOmega

NCT ID: NCT03267758 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Probiotic Supplementation on Endothelial Function II

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Researchers at MCW have discovered a new pathway that links the type of bacteria present in the intestines to the severity of heart attacks. This discovery of a relationship between intestinal bacteria, bacterial metabolites, and severity of heart attacks means that for the first time, the investigators may be able to determine a person's probability of having a heart attack via non-conventional risk factors. This may provide opportunities for novel diagnostic tests as well as a potential for therapeutic intervention. The link between gut microbiota and the severity of heart attacks may also lead to novel therapeutic approaches (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. The studies proposed will test the hypothesis that altered intestinal microbiota are mechanistically linked to the pathogenesis of cardiovascular disease. The investigator's objective is to determine whether inflammatory markers in the blood are decreased and endothelial cell function improved by a probiotic in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota regulates serum inflammatory markers. 1. Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO levels, conventional risk factors for cardiovascular disease and diabetes (total cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the intestinal microbiota (15 representative microbial groups) as non conventional risk factors. Several blood samples will be collected to measure biomarkers. Participants will provide periodic stool samples in order to measure gut bacterial biodiversity. Lastly, endothelial cell function (flow mediated dilation) will be measured in order to assess blood vessel function. 2. Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the intestinal microbiota as candidates for non-conventional risk factors of cardiovascular disease. The relationship between metabolites derived from the intestinal microbiota, endothelial cell function and risk factors for cardiovascular disease identified in Specific Aim 1 will be correlated.

NCT ID: NCT03127631 Recruiting - Prostate Cancer Clinical Trials

A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

RADICALPC
Start date: October 21, 2015
Phase: N/A
Study type: Interventional

RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

NCT ID: NCT03095261 Recruiting - Clinical trials for Cardiovascular Disease

Incentives in Cardiac Rehabilitation

Start date: September 2016
Phase: N/A
Study type: Interventional

The objective of this study is to examine whether a financial incentive program increases minutes of moderate-to-vigorous physical activity (MVPA) per week among cardiac rehabilitation (CR) graduates.

NCT ID: NCT02972619 Recruiting - Hypertension Clinical Trials

Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

Background: Hypertension is a serious public health problem responsible for significant mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years or older suffer from hypertension. Nearly half of these patients have uncontrolled hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to evaluate the effectiveness, cost effectiveness and impact on medication adherence of a well-structured program using multicomponent intervention for hypertension control aimed at overall cardiovascular risk reduction among individuals with hypertension attending the polyclinics in Singapore, compared to existing services. Such a program is expected to be cost-effective in terms of improving hypertensive individuals' outcomes, and to be potentially scalable and sustainable. Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized to intervention or usual care (4 each) and followed up for 2 years post randomization Intervention: The structured multicomponent primary care program comprises of: 1) algorithm-driven antihypertensive treatment for all hypertensive individuals and using fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals, 3) Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC antihypertensive medication Usual care: The participants attending polyclinics randomized to usual care will continue to receive treatment from the health providers according to existing practices. The hypertensive individuals will also continue to pay for the services (physician or nurse consultation) as per their existing model of reimbursement. Participants: A total of 1000 participants will be recruited, 125 from each of the 8 polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by randomization group). Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary outcome will be the change in systolic blood pressure from baseline to 2 years. Primary Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from baseline to end of follow-up at two years post randomization; 2) incremental cost per projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline to final follow-up at two-year post. The impact of effect on adherence to antihypertensive and lipid medication will be measured using data on adherence obtained from polyclinic pharmacy records and clinic notes. An average of percent adherence to antihypertensive and lipid lowering will be computed as a composite score. The change in percent composite adherence to antihypertensive and lipid medications from baseline to follow up will be compared between the intervention and control groups.

NCT ID: NCT02931500 Recruiting - Clinical trials for Cardiovascular Disease

Machine Learning for Identification of Future Disease Development: A Nationwide Cohort Study (MILESTONE)

Start date: July 1, 2016
Phase: N/A
Study type: Observational

To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease

NCT ID: NCT02931305 Recruiting - Osteoporosis Clinical Trials

Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.