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

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ClinicalTrials.gov Identifier: NCT02807532
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Shu Xu, General Hospital of Shenyang Military Region

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.

Condition or disease Intervention/treatment
Coronary Atherosclerotic Heart Disease Other: atrial fibrillation Other: non-atrial fibrillation

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Relationship Between Apelin and New-onset Atrial Fibrillation After Coronary Artery Bypass Grafting: a Prospective Cohort Study and Retrospective Case-Control Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

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

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




Primary Outcome Measures :
  1. Incidence of new-onset atrial fibrillation [ Time Frame: 7 days after surgery ]

Secondary Outcome Measures :
  1. Plasma apelin levels [ Time Frame: 7 days after surgery ]
    Apelin levels in circulating blood are associated with those in the cardiac atrium. Apelin is a cardiovascular polypeptide. The apelin receptor inhibits the angiotensin receptor, and is a protective factor against cardiovascular disease.

  2. Plasma brain natriuretic peptide level [ Time Frame: 7 days after surgery ]
    Atrial fibrillation can cause a marked increase in serum brain natriuretic peptide. Brain natriuretic peptide participates in the onset of atrial fibrillation and can be used to predict its occurrence.

  3. Plasma high-sensitivity C-reactive protein level [ Time Frame: 7 days after surgery ]
    High-sensitivity C-reactive protein(CRP) is a non-specific acute-phase reactive protein, and its levels are elevated in patients with coronary atherosclerotic heart disease, indicating involvement of the inflammatory response.

  4. Cardiac MRI evaluation [ Time Frame: 7 days after surgery ]
    To evaluate the degree of fibrosis of the left and right atrium and pulmonary veins



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807532


Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Principal Investigator: Shu Xu, Master The General Hospital of Shenyang Military Command, China

Responsible Party: Shu Xu, Attending Physician, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02807532     History of Changes
Other Study ID Numbers: GHShenyang_001
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases