Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03528382 |
| Other study ID # |
2016YFC1301105 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
September 29, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Harbin Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
