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Sleep DisorderNCT04636112

Sleep Habits and AMI and Gensini Score

An observational study of Sleep Disorder and Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sleep Disorder, Acute Myocardial Infarction
How many people
873 participants
Where
1 siteChina
Study dates
1 Apr 2019to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Effects of Sleep Habits on Acute Myocardial Infarction Risk and Severity of Coronary Artery Disease in Chinese Population

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.

Read the 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.

Keywords
sleep habits, sleep duration, daytime napping, Gensini score, late sleeping
Medical subject headings
Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04636112
Study groupRoleWhat they receive
control groupPatients 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 groupPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: in the last year before enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start1 Apr 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636112
Sponsor's protocol ID
NSFC
Status last verified
Nov 2020
First submitted
15 Nov 2020
Last updated
27 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.

    PubMed 26039963

  • Buxton OM, Marcelli E. Short and long sleep are positively associated with obesity, diabetes, hypertension, and cardiovascular disease among adults in the United States. Soc Sci Med. 2010 Sep;71(5):1027-36. doi: 10.1016/j.socscimed.2010.05.041. Epub 2010 Jun 16.

    PubMed 20621406

  • Nuyujukian DS, Beals J, Huang H, Johnson A, Bullock A, Manson SM, Jiang L; Special Diabetes Program for Indians Diabetes Prevention Demonstration Project. Sleep Duration and Diabetes Risk in American Indian and Alaska Native Participants of a Lifestyle Intervention Project. Sleep. 2016 Nov 1;39(11):1919-1926. doi: 10.5665/sleep.6216.

    PubMed 27450685

  • Kobayashi D, Takahashi O, Deshpande GA, Shimbo T, Fukui T. Association between weight gain, obesity, and sleep duration: a large-scale 3-year cohort study. Sleep Breath. 2012 Sep;16(3):829-33. doi: 10.1007/s11325-011-0583-0. Epub 2011 Sep 3.

    PubMed 21892668

  • Kim JY, Yadav D, Ahn SV, Koh SB, Park JT, Yoon J, Yoo BS, Lee SH. A prospective study of total sleep duration and incident metabolic syndrome: the ARIRANG study. Sleep Med. 2015 Dec;16(12):1511-5. doi: 10.1016/j.sleep.2015.06.024. Epub 2015 Sep 28.

    PubMed 26611949

  • Thomson CA, Morrow KL, Flatt SW, Wertheim BC, Perfect MM, Ravia JJ, Sherwood NE, Karanja N, Rock CL. Relationship between sleep quality and quantity and weight loss in women participating in a weight-loss intervention trial. Obesity (Silver Spring). 2012 Jul;20(7):1419-25. doi: 10.1038/oby.2012.62. Epub 2012 Mar 8.

    PubMed 22402738

  • Cappuccio FP, Stranges S, Kandala NB, Miller MA, Taggart FM, Kumari M, Ferrie JE, Shipley MJ, Brunner EJ, Marmot MG. Gender-specific associations of short sleep duration with prevalent and incident hypertension: the Whitehall II Study. Hypertension. 2007 Oct;50(4):693-700. doi: 10.1161/HYPERTENSIONAHA.107.095471. Epub 2007 Sep 4.

    PubMed 17785629

  • Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun;32(12):1484-92. doi: 10.1093/eurheartj/ehr007. Epub 2011 Feb 7.

    PubMed 21300732

  • Campos H, Siles X. Siesta and the risk of coronary heart disease: results from a population-based, case-control study in Costa Rica. Int J Epidemiol. 2000 Jun;29(3):429-37.

    PubMed 10869314

  • Sharma M, Sawhney JP, Panda S. Sleep quality and duration - potentially modifiable risk factors for Coronary Artery Disease? Indian Heart J. 2014 Nov-Dec;66(6):565-8. doi: 10.1016/j.ihj.2014.10.412. Epub 2014 Nov 4.

    PubMed 25634385

  • Xie D, Li W, Wang Y, Gu H, Teo K, Liu L, Yusuf S; INTERHEART China study Investigators. Sleep duration, snoring habits and risk of acute myocardial infarction in China population: results of the INTERHEART study. BMC Public Health. 2014 May 29;14:531. doi: 10.1186/1471-2458-14-531.

    PubMed 24885282

  • Wang D, Ruan W, Chen Z, Peng Y, Li W. Shift work and risk of cardiovascular disease morbidity and mortality: A dose-response meta-analysis of cohort studies. Eur J Prev Cardiol. 2018 Aug;25(12):1293-1302. doi: 10.1177/2047487318783892. Epub 2018 Jun 22.

    PubMed 29929393

  • Sinning C, Lillpopp L, Appelbaum S, Ojeda F, Zeller T, Schnabel R, Lubos E, Jagodzinski A, Keller T, Munzel T, Bickel C, Blankenberg S. Angiographic score assessment improves cardiovascular risk prediction: the clinical value of SYNTAX and Gensini application. Clin Res Cardiol. 2013 Jul;102(7):495-503. doi: 10.1007/s00392-013-0555-4. Epub 2013 Mar 23.

    PubMed 23519584

  • Yang WS, Fu WX, Wang X, Deng Q, Wang L, Wang LY, Zhao H, Fan WY, Huang SX. Comprehensive assessments of long-term sleep habits in epidemiological study: Validity and reliability of sleep factors questionnaire (SFQ) among Chinese women. J Psychosom Res. 2017 Apr;95:12-18. doi: 10.1016/j.jpsychores.2017.02.005. Epub 2017 Feb 10.

    PubMed 28314544

  • Taheri S, Lin L, Austin D, Young T, Mignot E. Short sleep duration is associated with reduced leptin, elevated ghrelin, and increased body mass index. PLoS Med. 2004 Dec;1(3):e62. doi: 10.1371/journal.pmed.0010062. Epub 2004 Dec 7.

    PubMed 15602591

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorder and Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a 17-item sleep factors questionnaire (time frame: in the last year before enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636112, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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