Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 AF burden during 3-day continuous ECG monitoring among 2 groups in pCAD-POAF trial 3 years after surgery.
The secondary outcomes are:1. Freedom of AF without the use of antiarrhymic medications or interventions ; 2. The occurence of MACCE (including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure); 3. AF incidence in 3 years and recorded by continuous ECG monitoring; 4. Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF; 5. The mean, maximum, and minimum heart rate recorded by Holter monitoring, as well as heart rate variability (HRV); 6. Quality of life assessment, such as EQ-5D-5L and AFEQT.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | This group underwent partial cardiac denervation procedure as well as CABG in the pCAD-POAF trial. However, no other intervention was performed after completing the pCAD-POAF trial. |
| |
| Control group | This group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no other intervention | Other | This is a observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AF burden | the AF burden during 3-day continuous ECG monitoring among 2 groups at the 3 year follow-up. | 3 year after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of AF without the use of antiarrhymic medications or interventions | Freedom of AF without the use of antiarrhymic medications or interventions | within 3 year after surgery |
| The occurence of MACCE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The population enrolled previously in pCAD-POAF trial.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Feng, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, CAMS & PUMC | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure
| within 3 year after surgery |
| AF incidence in 3 years and recorded by continuous ECG monitoring | AF incidence in 3 years and recorded by continuous ECG monitoring | 3 year after the surgery |
| Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF | Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF | within 3 year after surgery |
| The mean, maximum, and minimum heart rate and HRV | recorded by Holter monitoring at the 3 year follow-up visit | 3 year after the surgery |
| Assessment of quality of life | 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). | 3 year after the surgery |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |