Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02807532 |
| Other study ID # |
GHShenyang_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 13, 2016 |
| Last updated |
June 16, 2016 |
| Start date |
March 2015 |
| Est. completion date |
June 2015 |
Study information
| Verified date |
June 2016 |
| Source |
General Hospital of Shenyang Military Region |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
China: Ministry of Health |
| Study type |
Observational
|
Clinical Trial 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.
Description:
Atherosclerosis is a systematic and progressive pathological process, which commonly occurs
in the intima of large and medium-sized arteries. The disease can lead to degenerative,
proliferative, non-inflammatory lesions; thickening, hardening, and loss of elasticity of
the vascular wall, and vascular stenosis; and reduced arterial blood flow. Eventually, organ
damage occurs. Coronary atherosclerotic heart disease is the most common chronic
degenerative disease caused by atherosclerosis.
Coronary artery bypass grafting (CABG) can effectively increase myocardial blood supply,
prevent myocardial infarction, and improve quality of life, and is associated with low rates
of surgical complications and mortality. However, new-onset atrial fibrillation is a common
complication after coronary artery bypass grafting, with an incidence rate of 30%. It
induces hemodynamic instability, is often accompanied by left-ventricular systolic
dysfunction and congestive heart failure, and increases the risk of stroke.
Several studies have shown that the initiation and maintenance of atrial fibrillation is
strongly associated with inflammation, which affects the electrical and structural
remodeling of the heart. The role of C-reactive protein (CRP), a marker of inflammation, has
been widely investigated. C-reactive protein is a non-specific acute-phase protein, and is
elevated in many cardiovascular diseases, including coronary atherosclerotic heart disease,
heart failure and hypertension. Elevated C-reactive protein levels are not only associated
with simple and post-surgical atrial fibrillation, but also with cardioversion and
recurrence of atrial fibrillation after ablation. However, there is no elevation of
C-reactive protein levels in lone atrial fibrillation, indicating that inflammation is
associated with cardiovascular disease, but not with atrial fibrillation per se. One of the
aims of the present study is to determine how C-reactive protein levels in patients with
new-onset atrial fibrillation change after coronary artery bypass grafting.
Apelin has anti-inflammatory effects in different tissues. Ellinor et al. showed that levels
of apelin-12 were remarkably low in patients with atrial fibrillation. Recurrence of atrial
fibrillation is high in patients with persistent atrial fibrillation and low apelin-12
levels after electrical cardioversion.
Apelin is an endogenous ligand of the G-protein coupled receptor APJ, and exhibits homology
to angiotensin II. The signaling system stimulated by apelin regulates many physiological
functions and pathological processes. The main target of apelin is the cardiovascular
system; it dilates blood vessels, and has antifibrotic and positive inotropic effects.
Falcone et al. showed that the risk of recurrence of atrial fibrillation was 3.1 times
greater in patients with low apelin levels than those with high apelin levels. Furthermore,
Yang et al. concluded that apelin levels were lower in patients with different types of
atrial fibrillation than in controls, indicating that apelin might contribute to the
initiation and maintenance of atrial fibrillation.
The investigators carried out a literature search on the Web of Science and
ClinicalTrials.gov, using the search terms "apelin", "coronary artery bypass", and "atrial
fibrillation". The investigators also searched the Wanfang Database and China National
Knowledge Infrastructure, using the terms "apelin", "coronary atherosclerotic heart
disease", "surgery", and "atrial fibrillation"; or "apelin", "coronary atherosclerotic heart
disease", "coronary artery bypass grafting", and "atrial fibrillation". However, the
investigators found no clinical studies of the relationship between apelin and atrial
fibrillation after coronary artery bypass grafting. The investigators therefore designed the
present study to investigate this relationship.
In the cohort study, patients with coronary atherosclerotic heart disease scheduled to
undergo coronary artery bypass grafting will be assigned to high and low apelin groups,
according to preoperative apelin levels. The incidence of atrial fibrillation will be
compared between the two groups 7 days postoperatively. In addition, a case-control trial in
the same patients will compare plasma apelin levels and inflammatory response between those
patients with and without atrial fibrillation 7 days postoperatively.
Adverse events Adverse events after coronary artery bypass grafting will be recorded. These
might include myocardial infarction, myocardial ischemia, bradycardia, hypotension, and
stent thrombosis. The investigators will provide a detailed record of date of onset,
treatment-related processing method, and possible relationship with treatment. All adverse
reactions should be reported to the researcher in charge and clinical Institutional Review
Board within 24 hours.
Data collection, management, analysis and open access Data collection: A table will be
formulated for data collection according to the trial design. Data will be added to an
electronic database using a double data entry strategy.
Data management: Accuracy of information will be checked when all recruited patients are
followed up. The database will be locked by the researcher in charge and will not be
altered. All information relating to this trial will be preserved by The General Hospital of
Shenyang Military Region, China.
Data analysis: The electronic database will be fully disclosed to a statistician for
statistical analysis.
Open access: Published data will be available at www.figshare.com.
Statistical analysis Statistical analysis will be performed by a statistician blinded to
group assignment, using SPSS 19.0 software. If measurement data are normally distributed,
data will be expressed as mean ± SD, and count data will be expressed as percentages. P <
0.05 will be considered statistically significant.
In the cohort study, the chi-square test will be used to compare the incidence rate of
new-onset atrial fibrillation after coronary artery bypass grafting in patients with high
and low apelin levels.
In the case-control study, paired t-tests will be used to compare plasma apelin, brain
natriuretic peptide, and high-sensitivity C-reactive protein levels in patients with and
without atrial fibrillation. Multivariate logistic regression analysis will be applied to
determine the relationship between plasma apelin levels, cardiac fibrosis and inflammatory
response with atrial fibrillation after coronary artery bypass grafting.
Frequency and measures for monitoring trial implementation Trial progression will be
reported to the Ethics Committee of the General Hospital of Shenyang Military Region every
month and the trial's status will be updated in the registration database.
Confidentiality Test data, including medical records, will be saved electronically and in
hard copy. The electronic data will be preserved in a dedicated password-protected computer
and managed by a data manager. The paper data will be preserved in a secure, locked place by
the data manager and researcher in charge for future viewing.
