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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874481
• Other study ID #: T2018-ZX026
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2019
• Source: China National Center for Cardiovascular Diseases
• Contact: Hongjian Wang, Dr
• Phone: 13910008985
• Email: wanghongjianfw[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 958
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• In-stent Restenosis
• Myocardial Ischemia

Intervention

Other:
• Observation
follow up regularly for MACE

Locations

Country	Name	City	State
China	Hongjian Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent restenosis	The rate of in stent restenosis	9-12 months from PCI
Secondary	MACE	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	6months, 12months