Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.
Primary Purpose
Acute Coronary Syndrome
Status
Not yet recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
information reveal
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring cardiac rehabilitation, cardiopulmonary exercise testing
Eligibility Criteria
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
Sites / Locations
- Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CEPT informed
CPET not informed
Arm Description
the patient is informed and asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, as well as to take an important examination (cardiopulmonary exercise testing) for his/her cardiorespiratory fitness.
the patient is asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, but not informed about the cardiopulmonary exercise testing.
Outcomes
Primary Outcome Measures
the return rate
patient that did return to the OPD for examination and cardiac rehabilitation
Secondary Outcome Measures
the adherence
the percentage of patients that keep taking cardiac rehabilitation for more than one session
Full Information
NCT ID
NCT05401240
First Posted
May 29, 2022
Last Updated
July 13, 2022
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05401240
Brief Title
Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.
Official Title
Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
cardiac rehabilitation, cardiopulmonary exercise testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CEPT informed
Arm Type
Experimental
Arm Description
the patient is informed and asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, as well as to take an important examination (cardiopulmonary exercise testing) for his/her cardiorespiratory fitness.
Arm Title
CPET not informed
Arm Type
No Intervention
Arm Description
the patient is asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, but not informed about the cardiopulmonary exercise testing.
Intervention Type
Behavioral
Intervention Name(s)
information reveal
Intervention Description
the experimental group will be informed that there will be an important examination about his/her cardiopulmonary fitness condition at the outpatient department (OPD)
Primary Outcome Measure Information:
Title
the return rate
Description
patient that did return to the OPD for examination and cardiac rehabilitation
Time Frame
scheduled appointment time, about 2 to 4 weeks after discharge
Secondary Outcome Measure Information:
Title
the adherence
Description
the percentage of patients that keep taking cardiac rehabilitation for more than one session
Time Frame
6 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuchun Lee, MD
Phone
886-4-23592525
Ext
3507
Email
lyczoj@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuchun Lee, MD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.
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