Clinical trial NCT04993456: Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation
Official title: Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calcitonin Secretion Disorder
Post-operative Atrial Fibrillation
Keywords: Post-operative atrial fibrillation
Calcitonin
Cardiac surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is expected that 200 patients who received the first non-emergency cardiopulmonary bypass cardiac surgery in our hospital will be enrolled.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: POAF lasting longer than 30 seconds during the first week after cardiac surgery
timeFrame: 2 years after cardiac surgery
Secondary outcomes:
measure: The hospitalization days
timeFrame: 2 years after cardiac surgery
measure: Ventricular rate of the atrial fibrillation
timeFrame: 2 years after cardiac surgery
measure: Levels of serum calcitonin
timeFrame: 2 years after cardiac surgery
measure: Levels of serum procalcitonin
timeFrame: 2 years after cardiac surgery
measure: Levels of serum hsCRP
timeFrame: 2 years after cardiac surgery
measure: Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α)
timeFrame: 2 years after cardiac surgery
measure: Atrial fibrillation burden after cardiac surgery
timeFrame: lidan2014@tjh.tjmu.edu.cn
Other outcomes:
measure: Thromboembolic stroke
timeFrame: 2 years after cardiac surgery
measure: Serious bleeding events
timeFrame: 2 years after cardiac surgery
measure: All-cause mortality
timeFrame: 2 years after cardiac surgery
measure: Recurrence atrial fibrillaiton and readmission
timeFrame: 2 years after cardiac surgery
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: