Clinical trial NCT03905187: Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure
Official title: A Perspective Randomized Study of Impact of Stress Management Involved Cardiac Rehabilitation on Psychological States and Clinical Outcomes of Patients After Acute Myocardial Infarction or Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Heart Failure
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.

Detailed description: The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure

Exclusion Criteria:

* Uncontrolled tachycardia (heart rate at rest \>120bpm
* Uncontrolled polypnea（breath rate at rest \>30 breath per minute
* Uncontrolled respiratory failure （SPO2 ≤90%）
* Uncontrolled hypertension （pre-exercise SBP\>180mmHg or DBP\>110mmHg）
* Weight change in 72 hours \>1.8kg
* Uncontrolled hyperglycemia (Random blood glucose\>18mmol/L)
* Uncontrolled malignant arrhythmia with hemodynamic instability
* Unoperated pseudoaneurysm、artery dissection
* Uncontrolled septic shock and septicopyemia
* Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease
* nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
* Uncooperation of the patients

Primary outcomes:
measure: The score of anxiety test questionnaire decreased
timeFrame: 6 month
measure: The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
timeFrame: 6 month
measure: The score of patient health questionnaire decreased
timeFrame: 6 month
measure: The score of Chinese perceived stress scale decreased.
timeFrame: 6 month
Secondary outcomes:
measure: incidence of MACE in patients after acute myocardial infarction
timeFrame: 6 month
measure: incidence of MACE in patients with heart failure
timeFrame: 6 month
measure: improvement of exercise capacity
timeFrame: 6 month
measure: incidence of rehospitalization
timeFrame: 6 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Department of Cardiology in Chinese PLA General Hospital
name: Jing Ma
role: PRINCIPAL_INVESTIGATOR
References: