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

• Conditions: In-stent Restenosis; Coronary Artery Disease
• Interventions: Other: Observation

• Registration Number: NCT03874481
• Lead Sponsor: China National Center for Cardiovascular Diseases

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 Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-20
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 958

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI	Observation	Patients who had stent

Primary Outcome Measures

Name	Time	Method
In-stent restenosis	9-12 months from PCI	The rate of in stent restenosis

Secondary Outcome Measures

Name	Time	Method
MACE	6months, 12months	The rate of cardiovascular(CV) death (death due to a cardiovascular cause), myocardial infarction (MI) or Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization,Hospitalization for CV, Stroke, Death, Heart failure

Trial Locations

Locations (1)

Hongjian Wang; 🇨🇳 Beijing, Beijing, China