Cardiovascular Diseases Clinical Trials

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated. Read Less

In the United States, the growing Hispanic/Latino population is at high risk for type 2 diabetes and associated complications, yet underserved in healthcare and underrepresented in research. The purpose of this Sansum Diabetes Research Institute (SDRI) study is to create an HbA1c testing and support closed-loop system for U.S. Hispanic/Latino families. This loop will integrate Abbott's point-of-care (POC) technology with SDRI's Community Scientist Model to contact, test, intervene, and monitor Latinos with or at risk of type 2 diabetes for HbA1c levels. This study is built on prior work using specially trained Hispanic/Latino Community Scientists/Especialistas to support engagement with and encourage adherence to American Diabetes Association guidelines for HbA1c testing among Hispanic/Latino adults with type 2 diabetes. The study is an unblinded, nonrandomized, two arm self-controlled single center study. It is anticipated to run over 24 months and enroll 750 participants, in whom HbA1c will be measured over 6 months. This study will provide unique data on the burden of type 2 diabetes for Hispanic/Latino adults in Santa Barbara County, CA. In addition, the closed-loop approach will provide proof-of-concept evidence for scaling this approach to the larger Hispanic/Latino community to reduce the risk of poor outcomes due to type 2 diabetes and now COVID-19. Read Less

The primary aim of this randomized clinical trial is to compare the effects of three different HIIT protocols and a control group on cardiometabolic health in young adults with obesity. Participants will be randomly assigned to one of the following three groups, with each having varying work-to-rest ratios: 1) HIIT-A, 2) HIIT-B, 3) HIIT-C, and 4) control group. HIIT-A, HIIT-B, and HIIT-C groups will participate in six sessions of a running based HIIT program over a 2-week training period. Pre-clinical markers of cardiovascular disease, blood lipids and fasting glucose will be measured at the following three time points: baseline, post-intervention, and 2 weeks after the training cessation (i.e., measure for detraining effect). All measurements will be performed three days before the training program and three days after the intervention to avoid the effect of the last training session. Afterwards, the detraining test will be measured 2 weeks post intervention. Read Less

The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body. The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest. Read Less

A retrospective review of body composition changes in patients who participate in a 9-week non-invasive intensive health care provider supervised weight loss program as an overall cohort and in sub-cohorts of interest. Read Less

This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on plasma reduction-oxidation reactions of patients undergoing cardiac surgery requiring prolonged cardiopulmonary bypass. Read Less

This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass. Read Less

After the participant meets all inclusion and exclusion criteria, they will be randomized equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both groups will participate in an 8 week initial control period, followed by 8 weeks of supervised exercise training, followed by 8 weeks of deconditioning. All participants will undergo the same assessments and procedures one time prior to the initial 8 week control period, and at each of the three periods. Assessments include: blood draws; arterial stiffness testing; ultrasounds of the brachial artery to measure flow-mediated dilation (FMD); gluteal adipose tissue biopsies; exercise testing to determine VO2 max; body composition analysis via DEXA scans; ambulatory blood pressure measurement; diet analysis via food journals; medical history questionnaires; urine analysis for pregnancy; and activity monitoring via accelerometer. Total participation will be 24-26 weeks. Read Less

G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world. Read Less

Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders. Additionally, the study aims to: Evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis. Evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms. Direct participants to relevant and applicable clinical trials. Read Less

To evaluate the safety of [64Cu] Macrin and its whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. To detect [64Cu]-Macrin accumulation in sites of disease in subjects with cancer, sarcoidosis or myocardial infarct. Read Less

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and mortality in over 170 countries. Increasing age and burden of cardiovascular comorbidities are associated with a worse prognosis among patients with COVID-19. In addition, serologic markers of more severe disease including coagulation abnormalities and thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19 infection and are more common in patients who died in-hospital. As the COVID-19 pandemic continues to grow, there is a pressing need to identify safe, effective, and widely available therapies that can be scaled and rapidly incorporated into clinical practice. Understanding the putative mechanism of increased mortality risk associated with abnormal coagulation function and cardiac injury is critical to guide studies of promising therapeutic interventions. Published and anecdotal reports indicate that endothelial dysfunction and thrombosis are common in critically ill patients with COVID-19, including reports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys. Patients with cardiovascular disease (CVD) and CVD risk factors are known to have endothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19 inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mL was associated with an 18 times higher risk of in-hospital death, underscoring the importance of increased coagulation activity as a potential modifiable risk marker that may drive end-organ injury. Given the established link between endothelial dysfunction and thrombosis in patients with cardiovascular disease, and the association between coagulopathy and adverse outcomes in patients with sepsis, the association between increased coagulation activity, end-organ injury, and mortality risk may represent a modifiable risk factor among COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized, open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety. Read Less