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Exercise and Low-Dose Rapamycin in Older Adults with CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  1. Age 60 years or older
  2. Patients eligible to undergo cardiac rehabilitation.
  3. Informed written consent.

Exclusion criteria

  1. Class III or IV CHF.
  2. Creatinine > 2.0 mg/dl.
  3. HbA1c > 13%.
  4. Any malignancy
  5. Hematological disorder, including thrombocytopenia, leucopenia.
  6. Noncardiac illness expected to limit survival.
  7. Chronic liver disease.
  8. Suspected or known pregnancy.
  9. Geographically inaccessible or unable to return for follow-up.
  10. Unable to understand or cooperate with protocol requirements.
  11. Post organ transplant or with immune-compromised status
  12. Prior stroke with disability, severe Parkinson disease
  13. Dementia
  14. Post-CABG <3 months or any evidence of active wounds or ulcers.
  15. Anticipating elective surgery in the 3 months following enrollment.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Mandeep Singh, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20120573

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