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Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement, TAVR-FRAILTY Trial (TAVR-FRAILTY)
Eau Claire, Wis.,
The purpose of this study is to evaluate whether simple cardiac exercise interventions to improve physical performance before transcatheter aortic valve replacement (TAVR) surgery improves outcomes after TAVR.
Role of Exercise and Low-Dose Rapamycin on Age-Associated Impairments in Older Adults with Coronary Artery Disease: Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial (CARE)
Albert Lea, Minn.
The investigators will do the study in two phases. The first phase will be a pilot study on up to 18 participants [patients 60 years or older with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the duration of CR. Baseline and follow-up data will be collected for age-associated impairment (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory phenotype (SASP)and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes. Safety of rapamycin will be assessed by periodic clinical follow-up, blood draws, and serum rapamycin levels. Following completion of the pilot phase, the data will be analyzed. If favorable changes are noted in the SASP or AAI, the investigators will start a phase 2 randomized trial.
Second phase: In a prospective, randomized, clinical trial design, patients 60 years or older will be randomized at the time of CR to a standardized exercise protocol, or exercise protocol with the addition of low-dose rapamycin to test the hypothesis whether low-dose rapamycin (demonstrated in the pilot trial to improve SASP/AAI) will improve measures of AAI, SASP, or findings on the fat biopsy as compared to exercise alone. The null hypotheses are that there is no improvement with rapamycin in measures of AAI or SASP.
Routine Hemodynamic Monitoring following Percutaneous Coronary Interventions
We will identify the prevalence of hemodynamic abnormalities following percutaneous coronary interventions (PCI). Second, among patients with hemodynamic problems, we will be able to identify problems for which action needs to be taken. Third, pursuant to the results of our study, we can identify the clinical utility of such monitoring and will be able to target such monitoring to at-risk patients and will likely obviate the need for routine monitoring, propose cost-effectiveness measures, and propose same day discharge on low-risk patients.