Current partner codePEPTIDESDE
NCT04993456·Not applicable·OBSERVATIONAL

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

Status

Unknown

Phase

Not applicable

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

PROCEDURE

Caridac surgery

Cardiac surgery

Timeline

From registration to results.

  1. First posted

    Aug 6, 2021

  2. Study start

    Jun 15, 2021

  3. Primary completion

    Jul 15, 2023

  4. Study completion

    Jul 15, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 17, 2021

Outcomes

What the study measures.

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

The hospitalization days

Time frame · 2 years after cardiac surgery

The length of stay after the cardiac surgery

Ventricular rate of the atrial fibrillation

Time frame · 2 years after cardiac surgery

Ventricular rate of atrial fibrillation after the cardiac surgery

Levels of serum calcitonin

Time frame · 2 years after cardiac surgery

Levels of serum calcitonin of atrial fibrillation after the cardiac surgery

Levels of serum procalcitonin

Time frame · 2 years after cardiac surgery

Levels of serum procalcitonin of atrial fibrillation after the cardiac surgery

Levels of serum hsCRP

Time frame · 2 years after cardiac surgery

Levels 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)

Time frame · 2 years after cardiac surgery

Levels 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 surgery

Time frame · lidan2014@tjh.tjmu.edu.cn

Time and length of atrial fibrillation after cardiac surgery

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Tongji Hospital

Wuhan, Hubei, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

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