Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.

Acute Coronary Syndrome Clinical Trial

Official title:

Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401240
• Other study ID #: CE22225A
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Taichung Veterans General Hospital
• Contact: Yuchun Lee, MD
• Phone: 886-4-23592525
• Email: lyczoj[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Description:

Background: exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Hypothesis: cardiopulmonary exercise test (CPET) incentives ACS survivors to participate in outpatient cardiac rehabilitation.

Objectives: 200 ACS survivors who are eligible for cardiac rehabilitation will be allocated randomly into control and experimental groups.

Method: before discharge, both control and experimental groups will be informed of the importance of cardiac rehabilitation and invited to participate the outpatient rehabilitation. The experimental group will also be told that an important examination, i.e. the CPET, will be performed in order to evaluate their heart function at the outpatient department (OPD).

Primary outcome: the presence of ACS survivors at the OPD of rehabilitation in order to receive the rehabilitation/CPET.

Secondary outcomes: the adherence to cardiac rehabilitation, defined as completing a full course of cardiac rehabilitation (6 sessions) or home-based exercise.

Factors that might influence the presence of ACS survivors at OPD of rehabilitation will also be recorded and analyzed, including:

• Patient characteristics: age, sex, body mass index (BMI), cardiovascular disease (CVD) risk factors

• Electrocardiography (ECG): ST elevation myocardial infarction (STEMI) or non ST elevation myocardial infarction (NSTEMI)

• Lab data: peak troponin level.

• Days of hospitalization. Statistics: t-test, ANOVA

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• acute coronary patients

Exclusion Criteria:

• acute illness that stayed in hospital for more than 2 weeks.

• patients who received surgical intervention

• severe complications (ex. respiratory failure, stroke, acute renal failure)

• contraindications of cardiopulmonary exercise testing

• patients who cannot perform the cardiopulmonary exercise testing

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• information reveal
the experimental group will be informed that there will be an important examination about his/her cardiopulmonary fitness condition at the outpatient department (OPD)

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the return rate	patient that did return to the OPD for examination and cardiac rehabilitation	scheduled appointment time, about 2 to 4 weeks after discharge
Secondary	the adherence	the percentage of patients that keep taking cardiac rehabilitation for more than one session	6 months after discharge