Coronary Artery DiseaseEUROCADNCT02626806
Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
Who may be able to join
- Patients with suspected CAD, planned for diagnostic coronary angiogram
- Patients with previous revascularization, suspected of recurrent ischemia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven
Leuven, 3000
Marina Claes, bachelor nurse, 003216342461, marina.claes@uzleuven.be
Dries De Cock, MD, 003216341519, dries.decock@uzleuven.be
About this study
- To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
- To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
- 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
- Conditions
- Coronary Artery Disease
- Keywords
- exercise test, HS -troponin, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemodynamic significant CAD; | Not described | |
| patients without hemodynamic significant CAD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of coronary artery stenosis more than 50%
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Walter Desmet, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626806
- Sponsor's protocol ID
- UZL9281
- Acronym
- EUROCAD
- Status last verified
- Dec 2015
- First submitted
- 1 Apr 2014
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02626806
- Acronym / sponsor ID
- EUROCAD / UZL9281
- Conditions
- Coronary Artery Disease
- Keywords
- exercise test, HS -troponin, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
- To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hemodynamic significant CAD; | – | – |
| patients without hemodynamic significant CAD | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
Key inclusion criteria (2 listed)
- Patients with suspected CAD, planned for diagnostic coronary angiogram
- Patients with previous revascularization, suspected of recurrent ischemia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of coronary artery stenosis more than 50%
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dries De Cock, MD (003216341519, dries.decock@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of coronary artery stenosis more than 50% (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.