NCT02626806

Brief Summary

  1. 1.To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
  2. 2.To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
  3. 3.To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT level in predicting CAD, either alone or in relation to traditional patient-related and exercise test-related metrics

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-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

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

April 1, 2014

Last Update Submit

December 8, 2015

Conditions

Coronary Artery Disease

Keywords

exercise testHS -troponinCoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Presence of coronary artery stenosis more than 50%

    24 hours

Study Arms (2)

patients with hemodynamic significant CAD;

patients without hemodynamic significant CAD

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD

You may qualify if:

  • Patients with suspected CAD, planned for diagnostic coronary angiogram
  • Patients with previous revascularization, suspected of recurrent ischemia

You may not qualify if:

  • Congestive cardiomyopathy with LV EF \< 35%
  • Renal failure with eGFR \< 30 ml/min
  • Known structural or severe valvular heart disease
  • Prior CABG
  • Previous ACS \< 6 weeks
  • Known incomplete revascularization after previous PCI
  • Unstable angina or ACS (defined as unstable anginal symptoms + ECG changes or hs-TnT \> 0.053 ng/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Dries De Cock, MD

CONTACT

003216341519dries.decock@uzleuven.be

Nick Hiltrop, MD

CONTACT

003216344235nick.hiltrop@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic, Interventional Cardiology

Study Record Dates

First Submitted

April 1, 2014

First Posted

December 10, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

BE(1)