pCAD-POAF 3 Year Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorChina National Center for Cardiovascular Diseases
About this trial
This study will include the subjects who enrolled in pCAD-POAF trial (NCT05009914) to observe clinical outcomes 3 years after surgery.
The primary outcome is the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
The secondary outcomes are：the individual components of the primary composite outcome; unplanned all-cause rehospitalization; arrhythmias other than atrial fibrillation; premature atrial contraction and premature ventricular contraction burdens; heart rate variability parameters; quality-of-life scores; and other Holter-derived parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
This study will include the subjects who enrolled in pCAD-POAF trial
Disqualifiers
This study will include the subjects who enrolled in pCAD-POAF trial
Trial population
The population enrolled previously in pCAD-POAF trial.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no other intervention
Other interventionThis is a observational study.
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: Intervention group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation.
The primary outcome was the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
Time frame
3 year after the surgerySecondary outcomes
1
the individual components of the primary composite outcome
the individual components of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation
Time frame
within 3 year after surgery2
unplanned all-cause rehospitalization
unplanned all-cause rehospitalization
Time frame
within 3 year after surgery3
premature atrial contraction and premature ventricular contraction burdens
premature atrial contraction and premature ventricular contraction burdens recorded by the 3-day continuous ECG monitoring
Time frame
3 year after surgery4
Holter-derived parameter, mean heart rate
mean heart rate derived from the 3-day ECG monitoring
Time frame
3 year after the surgerySponsors and contacts
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Source ClinicalTrials.gov