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

Post-operative Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993456
• Other study ID #: TJ-CT-POAF
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: July 15, 2024

Study information

• Verified date: August 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-operative Atrial Fibrillation

Intervention

Procedure:
• Caridac surgery
Cardiac surgery

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thromboembolic stroke	Thromboembolic stroke	2 years after cardiac surgery
Other	Serious bleeding events	Serious bleeding events	2 years after cardiac surgery
Other	All-cause mortality	Cardiovascular, noncardiovascular or undetermined cause of death	2 years after cardiac surgery
Other	Recurrence atrial fibrillaiton and readmission	Recurrence atrial fibrillaiton and readmission	2 years after cardiac surgery
Primary	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	The hospitalization days	The length of stay after the cardiac surgery	2 years after cardiac surgery
Secondary	Ventricular rate of the atrial fibrillation	Ventricular rate of atrial fibrillation after the cardiac surgery	2 years after cardiac surgery
Secondary	Levels of serum calcitonin	Levels of serum calcitonin of atrial fibrillation after the cardiac surgery	2 years after cardiac surgery
Secondary	Levels of serum procalcitonin	Levels of serum procalcitonin of atrial fibrillation after the cardiac surgery	2 years after cardiac surgery
Secondary	Levels of serum hsCRP	Levels of serum hsCRP of atrial fibrillation after the cardiac surgery	2 years after cardiac surgery
Secondary	Levels of serum cytokines(IL-1ß,IL-2R,IL-6,IL-8,IL-10,TNF-a)	Levels of serum cytokines(IL-1ß,IL-2R,IL-6,IL-8,IL-10,TNF-a) of atrial fibrillation after the cardiac surgery	2 years after cardiac surgery
Secondary	Atrial fibrillation burden after cardiac surgery	Time and length of atrial fibrillation after cardiac surgery	lidan2014@tjh.tjmu.edu.cn