Coronary Artery Disease Clinical Trial
Official title:
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
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 the tele monitored exercise sessions performed in the community. Stress test will be preformed before the intervention and after completing 6 month.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 1, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise capacity | Stress bases METS assessment | 6 months | |
Secondary | Subject satisfaction | Questioner based assessment of program | 3 and 6 months | |
Secondary | Adherence to exercise program | Amount of time exercising at the specified target heart rate zone per week | 3 and 6 months | |
Secondary | Quality of life | QOL questioners | 3 and 6 months | |
Secondary | Device ease of use and technical difficulties | Questioners and transmission failures or usability issues | 1, 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions
|
N/A |