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NCT02960321 Clinical Trial

Troponin Release Induced by Procedure - Czech

Coronary Artery Disease Clinical Trial

— TRIP-CZ  

Official title:
Myocardial Injury Related to Coronary Angiography in the Era of High-sensitivity Cardiac Troponin I

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02960321
Other study ID # BN112016
Secondary ID
Status Completed
Phase N/A
First received November 6, 2016
Last updated January 4, 2017
Start date June 2016
Est. completion date June 2016

Study information
Verified date January 2017
Source Tomas Bata Hospital, Czech Republic
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Observational

Clinical Trial Summary

A prospective study aiming to analyse the relation between different variables and high sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary angiography with or without subsequent percutaneous coronary intervention.

Description:

The study tries to seek potential causes and context of subclinical myocardial injury within patients with baseline concentration of hsTnI below the 99th percentile value upper reference limit or with demonstrated fall of hsTnI levels.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- stable or unknown coronary artery disease

- acute coronary syndrome without ST-segment elevation meeting the criteria of low risk with demonstrated fall of cTn levels

Exclusion Criteria:

- acute coronary syndrome with persistent ST-segment elevation

- acute coronary syndrome without ST-segment elevation meeting the criteria of high or intermediate risk

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tomas Bata Hospital, Czech Republic

Outcome
Type Measure Description Time frame Safety issue
Primary Subclinical myocardial injury up to 24 hours after procedure No
Secondary Postprocedural myocardial infarction up to 24 hours after procedure No
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