NCT03874481

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
958

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

November 20, 2018

Last Update Submit

March 12, 2019

Conditions

Coronary Artery DiseaseIn-stent Restenosis

Keywords

sleep durationsleep qualitycoronary artery diseasein stent restenosis

Outcome Measures

Primary Outcomes (1)

  • In-stent restenosis

    The rate of in stent restenosis

    9-12 months from PCI

Secondary Outcomes (1)

  • MACE

    6months, 12months

Study Arms (1)

PCI

Patients who had stent

Other: Observation

Interventions

ObservationOTHER

follow up regularly for MACE

PCI

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Coronary arter disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongjian Wang

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseSleep Initiation and Maintenance Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Hongjian Wang, Dr

CONTACT

13910008985wanghongjianfw@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2018

First Posted

March 14, 2019

Study Start

November 1, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)