Exercise-induced High-sensitivity Troponin Levels as a Pr... | NCT02626806

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

NCT02626806

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Dec 10, 2015Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 1, 2014

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Dr Walter Desmet, Head of Clinic, Interventional Cardiology, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of coronary artery stenosis more than 50%		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dries De Cock, MD	Contact	003216341519		dries.decock@uzleuven.be
Nick Hiltrop, MD	Contact	003216344235		nick.hiltrop@uzleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZLeuven	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
patients with hemodynamic significant CAD;
patients without hemodynamic significant CAD