The Impact of Early Cardiac Rehabilitation of AMI Patients on the Incidence of Post-infarction HF
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After
      AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite
      the total ischemic time of AMI is decreasing in general at present, the incidence of HF after
      AMI remains high. The incidence of HF in Switzerland and the United States are 25% and
      14-16%, respectively, and the epidemiological statistic of AMI in the past 10 years was
      lacking in China, but the rate has been exceeded 22% by conservative estimation. Early
      cardiac rehabilitation quality improvement system has been shown to reduce incidence of
      post-infarction HF and improve cardiovascular function. However, early cardiac rehabilitation
      has low proportion and poor quality, which lacks of standard.

      Objective: The purposes of this quality improvement study are to evaluate a pointed,
      two-phase intervention system to improve the proportion and quality of cardiac
      rehabilitation; to standardize the early cardiac rehabilitation procedure to improve the
      prognosis among patients with post-infarction HF.

      Methods: Including the period I of cardiac rehabilitation, pre-discharge (baseline)
      assessment and the period II of cardiac rehabilitation.

      Statistical analysis: Data analyses are performed using the software package SAS version 9.2
      and all tests are 2-sided with P<0.05 denoting statistical significance. Quantitative data
      changes between groups which are compared with using the paired Student's t test and Wilcoxon
      rank sum test according to the data distribution, and categorical data is analyzed by
      chi-square test and ranked data is analyzed by Wilcoxon rank sum test. The investigator
      compare the incidence of heart failure in early rehabilitation patients between two phases
      according to the chi-square test of the rate of two groups, to explore the role of early
      cardiac rehabilitation after AMI in reducing the incidence of HF after AMI.
    

Detailed description: 
      Study design: After admission, and following clinical and diagnostic evaluation (12-lead
      electrocardiogram, Doppler echocardiography, symptom-limited cardiopulmonary exercise test
      and other related laboratory tests), all patients are discharged in low risk group (ejection
      fraction≥50% with AMI single-vessel lesion, emergency vascular recanalization without
      complication) and intermediate/high risk group (EF<50%, AMI partial blood transport
      reconstruction/multi-branch lesion, combined or uncombined with cardiogenic shock or heart
      failure). Researchers will assess inclusion and exclusion criteria, and patients who met the
      inclusion criteria need provide informed written consent in duplicate. All patients are
      enrolled in one I period rehabilitation during hospitalization and II period cardiac
      rehabilitation after discharge according to the different group. After 1 month, 2 months and
      6 months, all patients undergo a telephone or outpatient follow-up assessment including
      training, smoking, drug usage and nutrient assessment. And after 3 months and 12 months, all
      patients undergo an outpatient follow-up assessment by 6-minute walking test and/or
      cardiopulmonary exercise test and three psychological scales (SF-12， GAD-7 and PHQ-9),
      besides the above.

      The period I of cardiac rehabilitation: Patients who provide informed consents should assess
      indications and contraindications at first. The indications are: 1) no new emerging/repeated
      chest pain in 8 hours; 2) no further increase in the level of cardiac markers or cardiac
      enzymes (creatine kinase and troponin); 3) no obvious sign of decompensation of heart failure
      (the resting breath is difficult, combined with moist rale); 4) no new malignant arrhythmias
      or new electrocardiogram ischemic changes in the last 8 hours. The contraindications are: 1)
      hemodynamic instability or resting angina pectoris; 2) uncontrollable arrhythmia; 3) unable
      to rehabilitation due to disability or disease sequelae.

      The period I of cardiac rehabilitation for low risk group is divided into five phases and
      each phase has three parts. The three parts are daily life (from complete rest in bed, low
      fat liquid diet to partly provided for themselves, low fat and semi-liquid diet to basically
      provided for themselves, low fat diet), rehabilitation exercise training (from passive joint
      exercises in bed to stand by bed and walk) and publicity and education (including
      introduction about cardiovascular intensive care unit, rehabilitation procedure, smoking
      cessation, risk factors of coronary heart disease, etc.). The period I of cardiac
      rehabilitation for intermediate/high risk group is divided into seven phases and each phase
      has three parts as well as the low risk group, but each part is more cautious than low-risk
      group.

      Pre-discharge (baseline) assessment: One day before discharge, researchers should complete
      the assessment about patients who completed I period cardiac rehabilitation and fill in the
      cardiac rehabilitation quality feedback form. The assessments are as follows: 1) medical
      history assessment: recording patient medical history (coronary heart disease, hypertension,
      cerebrovascular disease, and/or peripheral vascular disease, hyperlipidemia, diabetes,
      congestive heart failure and chronic obstructive pulmonary disease, etc.); 2) physical
      examination: recording the heart rate, blood pressure and respiration of patients; checking
      whether there are engorgements of the neck veins, lung rale, cardiac souffle, arrhythmias and
      dropsy, etc; 3) accessory examination: recording the latest electrocardiogram and
      echocardiographic results); 4) nutrition assessment: assessing whether the patient is on
      high-fat diet or (and) high-salt diet and obese, setting a target weight based on BMI; 5)
      smoking assessment: assessing smoking status and let patients fill out the Fagerstrom test
      for nicotine dependence (FTND); 6) psychological assessment: let patients fill out the SF-12,
      GAD-7 and PHQ-9; 7) motor assessment: recording the maximum exercise load, the changes of
      heart rate and blood pressure from resting to maximum exercise load and rehabilitation
      process, terminal symptoms (angina and electrocardiogram abnormality), peak oxygen uptake,
      anaerobic threshold and alveolar air volume/carbon dioxide slope, through cardiopulmonary
      exercise test; 8) drug assessment: assessing and recording the name, dosage and usage of the
      drug; 9) adverse event assessment: assessing whether the patient with new or recurrent heart
      cerebral vascular disease, death and other adverse events when hospitalization, this part
      should be filled in the adverse event table; 10) Matters needing attention: Informing the
      patient or his family of precautions during the rehabilitation procedure and marking the
      doctor's contact number in the informed consent form, any hospitalization, reinfarction, or
      death should be immediately notified to the doctor.

      The period II of cardiac rehabilitation: This period should last three months after discharge
      from the hospital. Exercise rehabilitation is based on aerobic exercise, and combined with
      resistance and flexibility exercises, including warm-up period (5-10 minutes), training
      period (20-40 minutes) and cool-down period (at least 5 minutes). Aerobic training should
      begin from discharge, at least 3 times per week and resistance training should begin in at
      least five weeks after AMI, 1 time per week at first. In addition, researchers should provide
      counseling about living habit and drug taking. Psychological counseling would be given to
      patients who have anxiety or depression.
    

Intervention name(s): Cardiac rehabilitation quality improvement system
Intervention type(s): Behavioral
Intervention description(s): Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment