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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Albert Lea, Minnesota: 11-007896
    • Austin, Minnesota: 11-007896
    • Rochester, Minnesota: 11-007896
    NCT ID: NCT01649960
    Sponsor Protocol Number: 11-007896

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Albert Lea, Minn.

Mayo Clinic principal investigator

Mandeep Singh, M.D.

Closed for enrollment

Contact information:

Dawn Shelstad

(507)255-0473

shelstad.dawn@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Mandeep Singh, M.D.

Closed for enrollment

Contact information:

Dawn Shelstad

(507)255-0473

shelstad.dawn@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Mandeep Singh, M.D.

Closed for enrollment

Contact information:

Dawn Shelstad

(507)255-0473

shelstad.dawn@mayo.edu

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CLS-20120573

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