Sleep Habits and AMI and Gensini Score

NCT04636112 | Completed

• 1 other identifier: NSFC
• Study Type: observational
• Target: 873
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Acute Myocardial Infarction

Keywords

sleep habits; sleep duration; daytime napping; Gensini score; late sleeping

Outcome Measures

Primary Outcomes (1)

• a 17-item sleep factors questionnaire

  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.

  in the last year before enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• underwent coronary angiography;
• can complete sleep factors questionnaire.

You may not qualify if:

• mental diseases;
• sleep apnea;
• chronic obstructive pulmonary disease;
• stroke sequelae;
• arthritis;
• renal failure;
• tumor and a history of revascularization.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Wang Liansheng

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: April 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)