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Clinical Trials/NCT04993456
NCT04993456
Unknown
Not Applicable

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

Tongji Hospital1 site in 1 country200 target enrollmentJune 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Calcitonin Secretion Disorder
Sponsor
Tongji Hospital
Enrollment
200
Locations
1
Primary Endpoint
POAF lasting longer than 30 seconds during the first week after cardiac surgery
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
July 15, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Li Ni

Division of Cardiology, Department of Internal Medicne

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of no history of atrial fibrillation/flutter;
  • Heart rate ≥50 beats/min;
  • No history of emergency cardiac surgery in our hospital;
  • Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.

Exclusion Criteria

  • Atrial fibrillation/flutter;
  • Left atrial diameter \>5.5cm;
  • Previous cardiac surgery or emergency surgery (\<12h);
  • Sick sinus node syndrome;
  • Ventricular preexcitation or preexcitation syndrome;
  • Second degree or above atrioventricular block;
  • 7.Myocardial infarction occurred within 7 days;
  • Infection, sepsis, rheumatic or inflammatory diseases;
  • Abnormal liver and kidney function (three times higher than the upper limit of normal);
  • Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism;

Outcomes

Primary Outcomes

POAF lasting longer than 30 seconds during the first week after cardiac surgery

Time Frame: 2 years after cardiac surgery

The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery

Secondary Outcomes

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

Study Sites (1)

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