A Systematic Review of Ongoing Registered Research Studies on Post-Operative Atrial Fibrillation after Cardiac Surgery
Abstract
:1. Introduction
2. Materials and Methods
- Participants were undergoing or had undergone cardiac surgery via sternotomy or a minimally invasive surgical approach.
- Participants were aged 18 or above.
- POAF was used to define the study population or evaluated as a primary outcome.
- The study status in the registry record was most recently updated on 1 January 2017, or later.
3. Results
3.1. Prediction
3.2. Prevention
3.3. Detection
3.4. Management
4. Discussion
5. Conclusions
Author Contributions
Funding
Data Availability Statement
Conflicts of Interest
Appendix A
Ongoing Trials n = 121 | |
---|---|
Study theme | |
Prediction (%) | 21 (17.4) |
Prevention (%) | 77 (63.6) |
Detection (%) | 7 (5.8) |
Management (%) | 16 (13.2) |
Study design | |
Randomized experimental (%) | 82 (67.8) |
Nonrandomized experimental (%) | 13 (10.7) |
Observational (%) | 26 (21.5) |
Trial registry | |
Clinicaltrials.gov (%) | 68 (56.2) |
IRCT (%) | 17 (14.0) |
ChiCTR (%) | 11 (9.1) |
UMIN-CTR (%) | 9 (7.4) |
CTRI (%) | 5 (4.1) |
Dutch trial registry (%) | 4 (3.3) |
EUCTR (%) | 4 (3.3) |
ANZCTR (%) | 2 (1.7) |
ISRCTN (%) | 1 (0.8) |
Classes of Interventions | Examples | n * (% Management Studies) |
---|---|---|
Antiarrhythmic | Amiodarone, nifekalant, vernakalant | 6 (37.5) |
Anticoagulant | Warfarin, rivaroxaban, edoxaban, apixaban | 5 (31.3) |
Beta-blockers | Landiolol, bisoprolol, metoprolol | 2 (12.5) |
Recurrence monitoring | Implantable loop recorder, photoplethysmography | 2 (12.5) |
Rate controlling | Digoxin | 1 (6.3) |
Cardioversion | Low-energy cardioversion | 1 (6.3) |
Pacing | Biatrial pacing | 1 (6.3) |
Other | Antiplatelets, acupuncture | 2 (12.5) |
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Category | Examples | n * (% Predictive Studies) |
---|---|---|
Atrial imaging | Magnetic resonance imaging, 2D echocardiography, computed tomography, fibrosis patterns | 9 (42.9) |
Biomarkers | Inflammatory cytokines, fibrotic markers, lactate, aldosterone, homocysteine, endothelin-1, myeloperoxidase, brain natriuretic peptide, pro-collagen-1, calcitonin | 6 (28.6) |
Electrocardiography | P-wave characteristics, signal-processed surface electrocardiography | 3 (10.0) |
Demographic and past medical data | Risk factors (diabetes, hypertension, smoking), previous cardiac interventions, preoperative cardiac status, preoperative medication, type of operation, post-operative events, discharge | 3 (14.3) |
Gene expression | Atrial myocyte transcription and translation, IL-6 genotype | 2 (9.5) |
Other | Perioperative characterization of autonomic nervous system and microcirculation, perioperative anesthesia management, or not specified | 3 (14.3) |
Multi-variable ** | NCT05255224 (unspecified multimodal) NCT03169608 (perioperative characterization of the autonomic nervous system and microcirculation) ChiCTR-OCH-13003050 (genotype, serum biomarkers, ECG characteristics) CTRI/2022/11/047778 (ECG P-wave characteristics, imaging for left atrial strain) NCT03466125 (demographics, medical history, post-op events) NCT03962166 (electrocardiogram and echocardiography) NCT00614107 (atrial fibrosis and biomarkers) JPRN-UMIN000013673 (computed tomography of epicardial adipose, inflammation biomarkers) | 8 (38.1) |
Category | Examples | n * (% Prevention Studies) |
---|---|---|
Beta-blockers | Bisoprolol, metoprolol, landiolol, carvedilol | 11 (14.3) |
Antiarrhythmic | Amiodarone, dronedarone, sotalol | 11 (14.3) |
Vitamin and electrolyte supplementation | Magnesium sulfate, Vitamin C, selenium, potassium, tocotrienols | 11 (14.3) |
Autonomic nervous system modulation | Calcium autonomic denervation, stellate ganglion block, ganglionic plexi cryoablation, vagus nerve stimulation | 11 (14.3) |
Anesthetics/analgesics | Lidocaine, ropivacaine, low opioid protocols, dexmedetomidine | 8 (10.4) |
Paralytic | Botox | 6 (7.8) |
Anti-inflammatory | Hydrocortisone, minocycline, colchicine | 6 (7.8) |
Antihypertensive | Spironolactone, nitroprusside, metoral | 5 (6.5) |
Surgical interventions | Marshall ligament removal, Waterstone fat pad removal, left atrial appendage resection, cavoatrial annulation, biatrial cannulation, biatrial pacing | 4 (5.2) |
Statins | Atorvastatin, rosuvastatin | 4 (5.2) |
Ischemic Conditioning | Ischemic pre- and post-conditioning | 2 (2.6) |
Other | NP202, melatonin, ivabradine, dapagliflozin, Nux Vomica, anthocyanin-rich flour, clinician visits, human amniotic membrane | 8 (10.4) |
Category | Modality | Follow-Up Duration | n (Expected) Enrolment | Recruitment Status |
---|---|---|---|---|
Intermittent ECG | Single-lead and 4-lead ECG | 3 months post-op | 730 | Recruitment complete |
Handheld thumb ECG | 2 years post-op | 250 | Recruitment complete | |
Continuous ECG | Implantable loop recorder | 3 years post-op | 52 | Recruitment complete |
BraveHeart wearable ECG | 30 days post-discharge | 100 | Actively recruiting | |
Photoplethysmography | ScanWatch | 5 days post-op | 358 | Actively recruiting |
Fibricheck application | 30 days post-op | 300 | Not yet recruiting | |
Artificial intelligence | Artificial intelligence-assisted AF recognition | Not specified | 660 | Actively recruiting |
Study Design | Theme and Registry ID | Intervention; Comparator(s) | Primary Outcome(s) | N (Expected) Enrolment | Recruitment Status |
---|---|---|---|---|---|
Randomized Experimental | Rate or Rhythm Control ChiCTR2000033860 | Nifekalant; amiodarone | Cardioversion | 100 | Actively recruiting |
Rate or Rhythm Control NCT04748991 | Vernakalant; amiodarone | Cardioversion | 50 | Not yet recruiting | |
Rate or Rhythm Control NCT05169866 | Nifekalant; amiodarone | Cardioversion | 274 | Not yet recruiting | |
Rate or Rhythm Control ChiCTR2000039611 | Nifekalant; amiodarone | Maintenance of sinus rhythm | 100 | Actively recruiting | |
Rate or Rhythm Control NCT04223739 | Landiolol and oral bisoprolol; infused and oral amiodarone | Maintenance of sinus rhythm | 380 | Unknown (last known to be recruiting) | |
Rate or Rhythm Control NCT03525860 | Acupuncture; standard of care | Number of patients that complete acupuncture | 40 | Recruitment complete | |
Antithrombotic Strategies NCT03702582 | Rivaroxaban; warfarin | Post-operative length of stay | 300 | Actively recruiting | |
Antithrombotic Strategies NCT05300555 | Rivaroxaban; warfarin | Cost effectiveness via QALY | 50 | Actively recruiting | |
Antithrombotic Strategies NCT04045665 | Antiplatelet only; oral anticoagulant and antiplatelet | Composite of death, stroke, TIA *, MI *, and systemic arterial/venous thromboembolism | 3200 | Actively recruiting | |
Antithrombotic Strategies IRCT20200304046696N1 | Rivaroxaban; warfarin | Stroke, TIA *, and major bleeding | 1590 | Actively recruiting | |
Antithrombotic Strategies JPRN-UMIN000037139 | Apixaban; edoxaban | Bleeding and thromboembolic events | 200 | Terminated (not actively recruiting) | |
Monitoring for AF Recurrence NCT02522364 | Implantable loop recorder for 7 years; biannual clinician visit with Holter at 3 and 6 months | AF recurrence, MACCE *, implantation of pacemaker or ICD *, device complications, and major bleeding | 150 | Unknown (last known to be recruiting) | |
Nonrandomized Experimental | Antithrombotic Strategies JPRN-UMIN000021138 | Edoxaban | Stroke, TIA *, and major bleeding | 150 | Actively recruiting |
Observational | Rate or Rhythm Control NCT04804748 | Low-energy cardioversion w/biatrial pacing; w/o pacing | Cardioversion and POAF recurrence. | 450 | Not yet recruiting |
Rate or Rhythm Control NCT05165862 | Beta-blockers; digoxin; amiodarone | Maintenance of HR < 110 bpm | 54 | Recruitment complete | |
Monitoring for AF Recurrence NCT05664308 | Only ECG; ECG and photoplethysmography monitoring | Recurrence rate of AF | 106 | Not yet recruiting |
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Quan, I.; Belley-Côté, E.P.; Spence, J.; Wang, A.; Sidhom, K.; Wang, M.K.; Conen, D.; Sun, B.; Shankar, A.U.; Whitlock, R.P.; et al. A Systematic Review of Ongoing Registered Research Studies on Post-Operative Atrial Fibrillation after Cardiac Surgery. J. Clin. Med. 2024, 13, 4948. https://doi.org/10.3390/jcm13164948
Quan I, Belley-Côté EP, Spence J, Wang A, Sidhom K, Wang MK, Conen D, Sun B, Shankar AU, Whitlock RP, et al. A Systematic Review of Ongoing Registered Research Studies on Post-Operative Atrial Fibrillation after Cardiac Surgery. Journal of Clinical Medicine. 2024; 13(16):4948. https://doi.org/10.3390/jcm13164948
Chicago/Turabian StyleQuan, Ivy, Emilie P. Belley-Côté, Jessica Spence, Austine Wang, Karen Sidhom, Michael Ke Wang, David Conen, Bryan Sun, Aadithya Udaya Shankar, Richard P. Whitlock, and et al. 2024. "A Systematic Review of Ongoing Registered Research Studies on Post-Operative Atrial Fibrillation after Cardiac Surgery" Journal of Clinical Medicine 13, no. 16: 4948. https://doi.org/10.3390/jcm13164948