Calcitonin Level and New-onset of Post-Operative Atrial F... | NCT04993456

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

NCT04993456

Sponsor

Tongji Hospital

Status

Unknown status

Last Update Posted

Aug 17, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Calcitonin Secretion Disorder
Post-operative Atrial Fibrillation

Interventions

Caridac surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2021Actual

Primary Completion Date

Jul 15, 2023Estimated

Completion Date

Jul 15, 2024Estimated

First Submitted Date

Jun 24, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2021

Last Update Posted Date

Aug 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POAF group		the patients will have atrial fibrillation following the cardiac surgery	Procedure: Caridac surgery
non-POAF group		the patients will have no atrial fibrillation following the cardiac surgery	Procedure: Caridac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caridac surgery	Procedure	Cardiac surgery	POAF group non-POAF group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Thromboembolic stroke	Thromboembolic stroke	2 years after cardiac surgery
Serious bleeding events	Serious bleeding events	2 years after cardiac surgery

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

It is expected that 200 patients who received the first non-emergency cardiopulmonary bypass cardiac surgery in our hospital will be enrolled.

Sampling Method

Non-Probability Sample