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

March 12, 2019 updated by: Hongjian Wang, China National Center for Cardiovascular Diseases
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

958

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Hongjian Wang
        • Contact:
        • Contact:
          • Yin Dong
          • Phone Number: 13552582795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Coronary arter disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCI
Patients who had stent
Other: Observation
follow up regularly for MACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-stent restenosis
Time Frame: 9-12 months from PCI
The rate of in stent restenosis
9-12 months from PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 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
6months, 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

October 31, 2020

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2018-ZX026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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