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

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ClinicalTrials.gov Identifier: NCT01649960
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Mandeep Singh, Mayo Clinic

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Aging CAD Drug: Rapamycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Oral rapamycin was given during the nonrandomized phase of the study. The doses that were used of rapamycin were 0.5mg, 1mg, or 2mg.
Drug: Rapamycin
Oral tablets were given in the dose of 0.5mg, 1mg, or 2mg once a day. This was a pilot study and the serum rapamycin levels were kept below 6ng/ml.

Primary Outcome Measures :
  1. Frailty [ Time Frame: Twelve months ]
    Frailty will be measured using physical performance tests, gait speed, and grip strength.

Secondary Outcome Measures :
  1. Senescent-associated secretory phenotype [ Time Frame: twelve months ]
    The SASP will include interleukin 6, Matrix metalloproteinase 3, and Monocyte chemotactic protein 1.

Other Outcome Measures:
  1. Quality of life [ Time Frame: Twelve months ]
    Short-form 12 will be measured

  2. Mitochondrial DNA copy number and quantitation of senescent preadipocytes [ Time Frame: 12 weeks, before and after cardiac rehabilitation ]
    These variables will be analyzed by a fat biopsy (abdominal/thigh) before and following completion of cardiac rehabilitation.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649960

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United States, Minnesota
Mayo Clinic in Rochester and Mayo Health System sites in Austin and Albert Lea, Minnesota
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Mandeep Singh, MD Mayo Clinic
Publications of Results:
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Responsible Party: Mandeep Singh, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01649960    
Other Study ID Numbers: 11-007896
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Mandeep Singh, Mayo Clinic:
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs