NCT03518437

Brief Summary

The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the prognostic value of CTA, risk factors and bio-markers for MACE.

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
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 8, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

September 19, 2016

Last Update Submit

April 25, 2018

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseCTMACE

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events

    cardiac death, myocardial infarction (Cardiac death was defined as death due to acute myocardial infarction, ventricular arrhythmias, refractory heart failure or cardiogenic shock. The investigator reviewed all available data to determine whether a cardiac etiology was the immediate cause of death and categorized cardiac deaths into sudden cardiac death and nonsudden cardiac death. Sudden cardiac death was defined by published criteria . myocardial infarction was defined based on the criteria of typical chest pain, elevated cardiac enzyme levels and typical alterations of the electrocardiogram. )

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography (CT)

You may qualify if:

  • suspected of coronary heart disease, coronary CTA has been completed.
  • age \> 18 years old.
  • have biochemical test results.
  • signed informed consent.

You may not qualify if:

  • malignant tumor, severe liver and kidney diseases.
  • combination of cardiomyopathy, valvular disease, congenital heart disease, a variety of reasons the left cardiac insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binlu

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (4)

  • SCOT-HEART investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015 Jun 13;385(9985):2383-91. doi: 10.1016/S0140-6736(15)60291-4. Epub 2015 Mar 15.

    PMID: 25788230RESULT

  • Hou ZH, Lu B, Gao Y, Jiang SL, Wang Y, Li W, Budoff MJ. Prognostic value of coronary CT angiography and calcium score for major adverse cardiac events in outpatients. JACC Cardiovasc Imaging. 2012 Oct;5(10):990-9. doi: 10.1016/j.jcmg.2012.06.006.

    PMID: 23058065RESULT

  • Shah R, Foldyna B, Hoffmann U. Outcomes of anatomical vs. functional testing for coronary artery disease : Lessons from the PROMISE trial. Herz. 2016 Aug;41(5):384-90. doi: 10.1007/s00059-016-4451-3.

    PMID: 27333988RESULT

  • Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah M, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan K, Chow BJ, Delago A, Hadamitzky M, Hausleiter J, Kaufmann P, Maffei E, Raff G, Shaw LJ, Villines T, Berman DS; CONFIRM Investigators. Age- and sex-related differences in all-cause mortality risk based on coronary computed tomography angiography findings results from the International Multicenter CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry) of 23,854 patients without known coronary artery disease. J Am Coll Cardiol. 2011 Aug 16;58(8):849-60. doi: 10.1016/j.jacc.2011.02.074.

    PMID: 21835321RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

bio-markers of coronary artery disease

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • bin lu, M.D.

    Chinese Academy of Medical Sciences

    STUDY CHAIR

Central Study Contacts

bin lu, M.D.

CONTACT

88322656blu@vip.sina.com

Zhi-hui Hou, M.D.

CONTACT

88322656konglingyihui@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of radiology department

Study Record Dates

First Submitted

September 19, 2016

First Posted

May 8, 2018

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

May 8, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)