Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease

NCT ID: NCT02626806

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Brief Summary

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1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
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

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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exercise test HS -troponin Coronary artery disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with hemodynamic significant CAD;

No interventions assigned to this group

patients without hemodynamic significant CAD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients with suspected CAD, planned for diagnostic coronary angiogram
2. Patients with previous revascularization, suspected of recurrent ischemia

Exclusion Criteria

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

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr Walter Desmet

Head of Clinic, Interventional Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZLeuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dries De Cock, MD

Role: CONTACT

Phone: 003216341519

Email: [email protected]

Nick Hiltrop, MD

Role: CONTACT

Phone: 003216344235

Email: [email protected]

Facility Contacts

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Marina Claes, bachelor nurse

Role: primary

Dries De Cock, MD

Role: backup

Other Identifiers

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UZL9281

Identifier Type: -

Identifier Source: org_study_id