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Clinical Trials/NCT03874481
NCT03874481UnknownNot Applicable

The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis

China National Center for Cardiovascular Diseases1 site in 1 country958 target enrollmentStarted: November 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
958
Locations
1
Primary Endpoint
In-stent restenosis

Study Overview

Brief Summary

This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

Detailed Description

Background: Coronary artery disease (CAD) is the leading cause of mortality in the world. The important treatment of CAD is Percutaneous coronary intervention(PCI). However, in-stent-restenosis(ISR) is the major issue in the PCI. The factors of ISR include gender, age, diabetes, lipid ,obesity and so on.Recently, studies showed that sleep duration and sleep quality have effect on all of factors and have relationship with coronary artery calcification. We like to explore the relationship between sleep quality and CAD/ISR.

Aims:This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

Methods: We include patients who were diagnosed as CAD by coronary arteriography. Sleep duration and quality were evaluated from sleep questionnaire. During the 6 months and 9-12months, we follow up the patients who got PCI and get information of Major Adverse Cardiovascular Events (MACE) from follow-up questionnaire. On 9-12 months after PCI, coronary arteriography were produced in PCI patients. Biomarkers were tested during the follow-up.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Clinical diagnosis of Coronary artery disease
  • PCI patients in the follow-up
  • written informed consent

Exclusion Criteria

  • Heart failure; renal failure; secondary hypertension;valvular heart disease ;Cancer;

Outcomes

Primary Outcomes

In-stent restenosis

Time Frame: 9-12 months from PCI

The rate of in stent restenosis

Secondary Outcomes

  • MACE(6months, 12months)

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Hongjian Wang

Principal Investigator

China National Center for Cardiovascular Diseases

Study Sites (1)

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