Relationship Between Apelin and New-onset Atrial Fibrillation After Coronary Artery Bypass Grafting

NCT02807532 | Completed DMC

• 1 other identifier: GHShenyang_001
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate whether apelin can be used as an indicator to predict postoperative atrial fibrillation in patients with coronary atherosclerotic heart disease, and to provide an objective basis for the clinical selection of a preventive intervention program for atrial fibrillation.

Conditions

Coronary Atherosclerotic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of new-onset atrial fibrillation

  7 days after surgery

Secondary Outcomes (4)

• Plasma apelin levels

  7 days after surgery

• Plasma brain natriuretic peptide level

  7 days after surgery

• Plasma high-sensitivity C-reactive protein level

  7 days after surgery

• Cardiac MRI evaluation

  7 days after surgery

Study Arms (2)

atrial fibrillation group

In the case-control trial, patients with atrial fibrillation 7 days after surgery will be assigned to an atrial fibrillation group.

Other: atrial fibrillation

non-atrial fibrillation group

Patients without atrial fibrillation 7 days after surgery will be assigned to a non-atrial fibrillation group.

Other: non-atrial fibrillation

Interventions

atrial fibrillation OTHER

In the case-control trial, patients with atrial fibrillation 7 days after surgery will be assigned to an atrial fibrillation group.

atrial fibrillation group

non-atrial fibrillation OTHER

In the case-control trial, patients without atrial fibrillation 7 days after surgery will be assigned to a non-atrial fibrillation group.

non-atrial fibrillation group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary atherosclerotic heart disease, without a history of atrial fibrillation, and scheduled to undergo CABG. Their baseline data will be assessed according to inclusion and exclusion criteria. Up to 120 patients with coronary atherosclerotic heart disease scheduled to undergo coronary artery bypass grafting (CABG) will be recruited from the Department of Cardiac Surgery, General Hospital of Shenyang Military Region, China.

You may qualify if:

• Meet WHO diagnostic criteria for coronary atherosclerotic heart disease
• Are scheduled to undergo coronary artery bypass grafting
• Have no history of atrial fibrillation
• Have no history of thoracotomy
• Provide written informed consent, having understood the benefits and risks of participation in the trial

You may not qualify if:

• Valvular heart disease requiring surgical treatment
• Severe cerebrovascular disease
• Malignant tumor
• Severe autoimmune disease
• Thyroid dysfunction
• Severe infection
• Heart failure or acute myocardial infarction in the past month
• Severe dysfunction of the heart, liver or lung
• Refusal to cooperate with specimen collection and laboratory examination
• Ongoing participation in other clinical trials
• Unable to provide informed consent owing to mental disorders or language barriers

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Officials

• Shu Xu, Master

  The General Hospital of Shenyang Military Command, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 21, 2016

Record last verified: 2016-06