Status:
UNKNOWN
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
Lead Sponsor:
Sheba Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk according to national guidelines. We plan to gradually reduce the number of institution based CR and increase ...
Detailed Description
Following the standard rehabilitation intake process (physician visit, nurse intake, exercise physiologist consultation based on stress test and clinical data passed from the physician) all subjects w...
Eligibility Criteria
Inclusion
- Coronary disease (S/p ACS, PCI, CABG or stable angina with documented coronary disease)
- Age ≥ 21
- Smartphone with internet connection
- Willing and able to comply with study protocol and
- LVEF \> 40% and Baseline METS ≥ 5
- Able to follow the personalized exercise prescription, utilize smartwatch and upload exercise data per protocol
Exclusion
- Heart failure (clinical) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- Significant neurological or cognitive impairment
- Women of child-bearing potential
- Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value \<100 mmHg without symptoms
- ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
- Inability to perform a CPET test due to physical limitations
- Ischemia per stress test \\ nuclear scan or stress echocardiography
- Severe angina pectoris as defined by CCS \>2
- Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung involvement) or chronic pulmonary thromboembolic disease (CTED)
- Severe orthopedic limitations
- Active myocarditis, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy
- Moderate or severe Aortic or Mitral stenosis, moderate or severe mitral regurgitation due to primary valvular disease
- Significant anemia (Hb \<10 mg/dl)
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
- Any illness which reduces life expectancy to less than 1 year from screening
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03228225
Start Date
November 1 2017
End Date
August 1 2018
Last Update
June 26 2018
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel