NCT03473860

Brief Summary

The purpose of this study is to investigate the change of total cholesterol content of erythrocyte membranes (CEM) in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

March 15, 2018

Last Update Submit

March 21, 2018

Conditions

Coronary Artery Disease

Keywords

prognosisall-cause mortalitymyocardial infarctionstroke

Outcome Measures

Primary Outcomes (1)

  • the change of CEM

    the change of CEM

    before and 6-, 12-, 18-, 24- month after follow-up

Secondary Outcomes (6)

  • coronary revascularization

    24- months

  • heart failure

    24- months

  • all-cause mortality

    24- months

  • cardiovascular mortality

    24- months

  • non-fatal myocardial infarction

    24- months

  • +1 more secondary outcomes

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First diagnosis of CAD through CAG

You may qualify if:

  • Signed informed consent;
  • First diagnosis of CAD through CAG;
  • Aged 45-70.

You may not qualify if:

  • Patients with severe liver or kidney damage;
  • Taking statins within the last 3 months;
  • Patients who had been diagnosed with CAD and treated with oral medication;
  • Chronic diseases of the blood system;
  • Familial hyperlipidemia patients;
  • Patients combining autoimmune disease;
  • Patients combining acute infectious disease;
  • Patients who undertaken surgery or injury;
  • Patients who combining cancer;
  • Patients who taking glucocorticoid replacement therapy;
  • Abnormal red blood cell (RBC) count (M: \<4.0 or \>5.5 × 1012/L; F: \<3.5 or \>5.0 × 1012/L) or abnormal hemoglobin (M: \<120 or \>160 g/L; F: \<110 or \>150 g/L).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionStroke

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

April 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 22, 2018

Record last verified: 2018-03