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

• Conditions: Calcitonin Secretion Disorder; Post-operative Atrial Fibrillation
• Interventions: Procedure: Caridac surgery

• Registration Number: NCT04993456
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-07-28
• Status Verified: 2021-08
• Study First Posted: 2021-08-06
• Last Update Submitted: 2021-08-14
• Last Update Posted: 2021-08-17
• Primary Completion: 2023-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-POAF group	Caridac surgery	the patients will have no atrial fibrillation following the cardiac surgery
POAF group	Caridac surgery	the patients will have atrial fibrillation following the cardiac surgery

Primary Outcome Measures

Name	Time	Method
POAF lasting longer than 30 seconds during the first week after cardiac surgery	2 years after cardiac surgery	The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China