Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation

Study Overview
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Brief Summary
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Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery. However, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in POAF patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;P <0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with POAF (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;P < 0.0001). These data highlight the need to understand better the underlying mechanism of POAF. A latest research in Nature reported levels of circulating calcitonin (CT), which is the main risk factor for atrial fibrillation (AF). Global disruption of CT receptor signalling in mice causes atrial fibrosis and increases susceptibility to AF. Here we will explore the relationship between CT and POAF.

Official Title
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Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

Conditions
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Calcitonin Secretion Disorder, Post-operative Atrial Fibrillation

Intervention / Treatment
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* Procedure: Caridac surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical diagnosis of no history of atrial fibrillation/flutter; 2. Heart rate ≥50 beats/min; 3. EF > 40%; 4. No history of emergency cardiac surgery in our hospital; 5. Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years. Exclusion Criteria: 1. Atrial fibrillation/flutter; 2. Left atrial diameter >5.5cm; 3. Previous cardiac surgery or emergency surgery (<12h); 4. Sick sinus node syndrome; 5. Ventricular preexcitation or preexcitation syndrome; 6. Second degree or above atrioventricular block; 7.Myocardial infarction occurred within 7 days; 8. Infection, sepsis, rheumatic or inflammatory diseases; 9. Abnormal liver and kidney function (three times higher than the upper limit of normal); 10. Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism; 11. Any ischemic events (stroke or TIA) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/TIA;Thrombosis; 12. Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy; 13. Patients' life expectancy makes it unlikely that follow-up will be completed; 14. Participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period; 15. Patients with contraindications to dynamic electrocardiogram; 16. Patients who are unwilling or unable to fully comply with study procedures and follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAF group<br>the patients will have atrial fibrillation following the cardiac surgery | Procedure: Caridac surgery<br>* Cardiac surgery<br>|
| non-POAF group<br>the patients will have no atrial fibrillation following the cardiac surgery | Procedure: Caridac surgery<br>* Cardiac surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POAF lasting longer than 30 seconds during the first week after cardiac surgery | The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery | 2 years after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hospitalization days | The length of stay after the cardiac surgery | 2 years after cardiac surgery | 
| Ventricular rate of the atrial fibrillation | Ventricular rate of atrial fibrillation after the cardiac surgery | 2 years after cardiac surgery | 
| Levels of serum calcitonin | Levels of serum calcitonin of atrial fibrillation after the cardiac surgery | 2 years after cardiac surgery | 
| Levels of serum procalcitonin | Levels of serum procalcitonin of atrial fibrillation after the cardiac surgery | 2 years after cardiac surgery | 
| Levels of serum hsCRP | Levels of serum hsCRP of atrial fibrillation after the cardiac surgery | 2 years after cardiac surgery | 
| Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α) | Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α) of atrial fibrillation after the cardiac surgery | 2 years after cardiac surgery | 
| Atrial fibrillation burden after cardiac surgery | Time and length of atrial fibrillation after cardiac surgery | lidan2014@tjh.tjmu.edu.cn | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative atrial fibrillation, Calcitonin, Cardiac surgery