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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04993456
Other study ID # TJ-CT-POAF
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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