- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401240
Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.
Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
-
Taichung, Taiwan, Taiwan, 407
- Taichung Veterans General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CEPT informed
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 experimental group will be informed that there will be an important examination about his/her cardiopulmonary fitness condition at the outpatient department (OPD)
|
|
No Intervention: CPET not informed
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the return rate
Time Frame: scheduled appointment time, about 2 to 4 weeks after discharge
|
patient that did return to the OPD for examination and cardiac rehabilitation
|
scheduled appointment time, about 2 to 4 weeks after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the adherence
Time Frame: 6 months after discharge
|
the percentage of patients that keep taking cardiac rehabilitation for more than one session
|
6 months after discharge
|
Collaborators and Investigators
Investigators
- Study Director: Yuchun Lee, MD, Taichung Veterans General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE22225A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Chulalongkorn UniversityCompletedCKD | Coronary Angiography (CAG) | ACS (Acute Coronary Syndrome)
-
Mahidol UniversityNot yet recruitingCoronary Artery Disease | Acute Coronary Syndrome/ Myocardial InfarctionThailand
-
Shenyang Northern HospitalNot yet recruitingSGLT2 Inhibitors | ACS (Acute Coronary Syndrome)China
-
Aarhus University Hospital SkejbyAbbottEnrolling by invitationIschemic Heart Disease | Ischemic Coronary Artery Disease | ACS (Acute Coronary Syndrome)Denmark, Belgium, Finland, Sweden, Switzerland, Germany, Latvia, Norway, United Kingdom, Estonia, Netherlands, Italy
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Heart Care FoundationNovartis Farma S.p.A.Not yet recruitingAcute Coronary Syndromes | Chronic Coronary SyndromesItaly
-
University of GalwayNot yet recruitingMyocardial Ischemia | Percutaneous Coronary Intervention | Chronic Coronary Syndrome | Coronary Computed Tomography Angiography | Acute Coronary Syndromes (ACS) | Coronary Arteries Disease
-
Xiling QiRecruitingHF - Heart Failure | ACS (Acute Coronary Syndrome)China
-
Shenyang Northern HospitalChinese Academy of Medical Sciences, Fuwai HospitalNot yet recruitingCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS) | High Bleeding Risk(HBR)China
-
SUK MIN SEOBoston Scientific Korea Co. LtdRecruitingAcute Coronary Syndromes (ACS)South Korea
Clinical Trials on information reveal
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Ceevra, Inc.Completed
-
Medtronic Corporate Technologies and New VenturesCompletedEnd Stage Renal DiseaseUnited States, India
-
MedMira Laboratories Inc.Completed
-
Carolyn Zahler-MillerRecruitingType 2 Diabetes | Gestational Diabetes Mellitus in PregnancyUnited States
-
University of Dublin, Trinity CollegeUniversity of Copenhagen; Medtronic Bakken Research CenterRecruitingFrailty | Fall PatientsIreland
-
National and Kapodistrian University of AthensRecruitingStroke | Atrial Fibrillation | Stroke, Ischemic | Stroke, AcuteGreece
-
Medtronic Cardiac Rhythm and Heart FailureCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
Ceevra, Inc.CompletedKidney Cancer | Renal Cell CarcinomaUnited States
-
Ceevra, Inc.Completed