Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Almudena Castro Conde
- Enrollment
- 509
- Locations
- 1
- Primary Endpoint
- Adherence to physical exercise
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program
Investigators
Almudena Castro Conde
MD, PhD, Cardiology Department Staff, Hospital Universitario La Paz , Madrid
Spanish Society of Cardiology
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Equal or older 18 years old
- •Acute coronary syndrome with or without ST elevation within last two months
- •Being able to do physical exercise
- •Being able to understand the educative sessions
- •Being able to understand patient information in the consent form
Exclusion Criteria
- •Hemodynamic instability
- •Left ventricular ejection fraction (LVEF) \< or = 35%
- •Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
- •Refractory angina
- •Any pathology for which physical exercise is not indicated
Outcomes
Primary Outcomes
Adherence to physical exercise
Time Frame: baseline-12 months
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Adherence to Mediterranean diet
Time Frame: baseline-12 months
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Tabacco abstinence
Time Frame: baseline-12 months
Assessed by cooximetry (less dan 10 ppm)
Number of participants reporting compliance with prescribed treatments
Time Frame: baseline-12 months
Patient-reported answers form the investigator