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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Atrial Fibrillation; Calcitonin Secretion Disorder
• Intervention / Treatment: Procedure: Caridac surgery

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Li Ni, PHD; Phone Number: +862783662479; Email: nili@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
POAF group; the patients will have atrial fibrillation following the cardiac surgery	Procedure: Caridac surgery; Cardiac surgery
non-POAF group; the patients will have no atrial fibrillation following the cardiac surgery	Procedure: Caridac surgery; Cardiac surgery

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic stroke	Thromboembolic stroke	2 years after cardiac surgery
Serious bleeding events	Serious bleeding events	2 years after cardiac surgery
All-cause mortality	Cardiovascular, noncardiovascular or undetermined cause of death	2 years after cardiac surgery
Recurrence atrial fibrillaiton and readmission	Recurrence atrial fibrillaiton and readmission	2 years after cardiac surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): July 15, 2024

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac surgery; Calcitonin; Post-operative atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TJ-CT-POAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No