Coronary Artery Disease, Atrial Fibrillation
Conditions
Keywords
coronary artery disease, atrial fibrillation
Brief summary
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.
Detailed description
This study aimed to observe clinical outcomes 3 years after surgery in patients enrolled in pCAD-POAF trial. After completing the pCAD-POAF trial, investigators would not make any other interventions on enrolled patients. At the 3 year follow-up visit, all subjects will undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG). Besides, coronary computed tomographic angiography(CCTA) will be performed depending on their own willingness. In the meantime, all subjects will be continuously monitored by wearing specific device for the detection of arrhythmias. Data collection will also include the use of medications, medical tests, any documented arrhythmias and the occurrence of clinical events within the 3 years. In conclusion, this is a extensive follow-up of previous RCT and a non-interventional, observational study.
Interventions
This is a observational study.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* This study will include the subjects who enrolled in pCAD-POAF trial
Exclusion criteria
* This study will include the subjects who enrolled in pCAD-POAF trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation. | 3 year after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the individual components of the primary composite outcome | within 3 year after surgery | the individual components of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation |
| unplanned all-cause rehospitalization | within 3 year after surgery | unplanned all-cause rehospitalization |
| premature atrial contraction and premature ventricular contraction burdens | 3 year after surgery | premature atrial contraction and premature ventricular contraction burdens recorded by the 3-day continuous ECG monitoring |
| Holter-derived parameter, mean heart rate | 3 year after the surgery | mean heart rate derived from the 3-day ECG monitoring |
| Holter-derived parameter, HRV | 3 year after the surgery | HRV derived from the 3-day ECG monitoring |
| Assessment of quality of life | 3 year after the surgery | Assessed by EQ-5D-5L (EuroQol 5-Dimensions 5-Levels questionnaire, higher score means better outcome) and AFEQT (Atrial-Fibrillation-Effect-on-Quality-of-life-Questionnaire, higher score means better outcome). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Feng, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed