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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04993456
Enrollment
200
Registered
2021-08-06
Start date
2021-06-15
Completion date
2024-07-15
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcitonin Secretion Disorder, Post-operative Atrial Fibrillation

Keywords

Post-operative atrial fibrillation, Calcitonin, Cardiac surgery

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.

Interventions

PROCEDURECaridac surgery

Cardiac surgery

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POAF lasting longer than 30 seconds during the first week after cardiac surgery2 years after cardiac surgeryThe incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery

Secondary

MeasureTime frameDescription
Levels of serum calcitonin2 years after cardiac surgeryLevels of serum calcitonin of atrial fibrillation after the cardiac surgery
Levels of serum procalcitonin2 years after cardiac surgeryLevels of serum procalcitonin of atrial fibrillation after the cardiac surgery
Levels of serum hsCRP2 years after cardiac surgeryLevels 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 surgeryLevels of serum cytokines(IL-1β,IL-2R,IL-6,IL-8,IL-10,TNF-α) of atrial fibrillation after the cardiac surgery
Atrial fibrillation burden after cardiac surgerylidan2014@tjh.tjmu.edu.cnTime and length of atrial fibrillation after cardiac surgery
The hospitalization days2 years after cardiac surgeryThe length of stay after the cardiac surgery
Ventricular rate of the atrial fibrillation2 years after cardiac surgeryVentricular rate of atrial fibrillation after the cardiac surgery

Other

MeasureTime frameDescription
All-cause mortality2 years after cardiac surgeryCardiovascular, noncardiovascular or undetermined cause of death
Recurrence atrial fibrillaiton and readmission2 years after cardiac surgeryRecurrence atrial fibrillaiton and readmission
Thromboembolic stroke2 years after cardiac surgeryThromboembolic stroke
Serious bleeding events2 years after cardiac surgerySerious bleeding events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026