Clinical trial NCT04636112: Sleep Habits and AMI and Gensini Score
Official title: Effects of Sleep Habits on Acute Myocardial Infarction Risk and Severity of Coronary Artery Disease in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Acute Myocardial Infarction
Keywords: sleep habits
sleep duration
daytime napping
Gensini score
late sleeping
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Jiangning Hospital of Nanjing Medical University
First posted: 2020-11-19
Enrollment: 873
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A case-control study was designed to investigate the effects of sleep habits on AMI and severity of CAD. After patients were in stable condition, trained physicians administered a questionnaire survey by a face-to-face interview. Information on demographic characteristics, hypertension, diabetes and dyslipidemia history, drug use, smoking, drinking, dietary habits, exercise and sleep habits were collected.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: a 17-item sleep factors questionnaire
timeFrame: in the last year before enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wang Liansheng
role: STUDY_DIRECTOR
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