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Sleep Habits and AMI and Gensini Score

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04636112
Collaborator
The Affiliated Jiangning Hospital of Nanjing Medical University (Other)
873
Enrollment
1
Location
15
Actual Duration (Months)
58.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Growing evidence indicates that poor sleep harms health. Early to bed and early to rise is considered as a healthy lifestyle in Chinese population. The current study aimed to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients including 314 with AMI were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. 559 controls included 395 CAD cases and 164 non-CAD cases. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview. The severity of CAD was assessed by Gensini score in AMI and CAD groups. The effects of sleep factors on AMI risk and Gensini score were examined by unconditional logistic regression. The timing of sleep (24:00 and after), sleep duration (<6h) and frequency of night-time waking (3 times) increased the risk of AMI. In subjects with age ≤60 years, daytime napping reduced the risk of AMI. The correlation between sleep quality and AMI became insignificant after subgroup analysis by age. Short sleep duration also increased the risk of high Gensini score.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    873 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Effects of Sleep Habits on Acute Myocardial Infarction Risk and Severity of Coronary Artery Disease in Chinese Population
    Actual Study Start Date :
    Apr 1, 2019
    Actual Primary Completion Date :
    Jun 30, 2020
    Actual Study Completion Date :
    Jun 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    control group

    Patients hospitalized and diagnosed as non-AMI during the same time period were matched. All patients underwent coronary angiography and CAD was defined as at least one main coronary artery with > 50% narrowing of luminal diameter.
    AMI group

    Patients were diagnosed as MI when a cardiac biomarker (preferably cardiac troponin) rose or fell at least one value in its 99th percentile upper reference limit and at least one of the following criteria was met, including ischemic symptoms, electrocardiogram (ECG) changes of new ischemia, pathologic Q waves in the ECG, imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, identification of an intracoronary thrombus by angiography or autopsy.

    Outcome Measures

    Primary Outcome Measures

    1. a 17-item sleep factors questionnaire [in the last year before enrollment]

      SFQ included sleep quality, sleep duration at night, timing of sleep and waking up, insomnia and night-time waking frequency, sleep medication use, night work, daytime napping, light at night (LAN) exposure and sleep noise.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. underwent coronary angiography;

    2. can complete sleep factors questionnaire.

    Exclusion Criteria:

    1. mental diseases;

    2. sleep apnea;

    3. chronic obstructive pulmonary disease;

    4. stroke sequelae;

    5. arthritis;

    6. renal failure;

    7. tumor and a history of revascularization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210029

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University
    • The Affiliated Jiangning Hospital of Nanjing Medical University

    Investigators

    • Study Director: Wang Liansheng, The First Affiliated Hospital with Nanjing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Liansheng Wang, Professor, The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT04636112
    Other Study ID Numbers:
    • NSFC
    First Posted:
    Nov 19, 2020
    Last Update Posted:
    Nov 27, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liansheng Wang, Professor, The First Affiliated Hospital with Nanjing Medical University
    sleep habits
    sleep duration
    daytime napping
    Gensini score
    late sleeping
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Nov 27, 2020