NCT02960321

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Status
completed

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

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

Same day

First QC Date

November 6, 2016

Last Update Submit

January 4, 2017

Conditions

Coronary Artery Disease

Keywords

myocardial injuryhigh-sensitivity troponin Iperiprocedural myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Subclinical myocardial injury

    up to 24 hours after procedure

Secondary Outcomes (1)

  • Postprocedural myocardial infarction

    up to 24 hours after procedure

Study Arms (2)

CAG without PCI

Diagnostic coronary angiography only

CAG with PCI

Diagnostic coronary angiography and subsequent percutaneous coronary intervention (PCI)

Eligibility Criteria

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

Consecutive patients referred for coronary angiography (CAG): stable patients with presumed coronary artery disease, or those referred for acute coronary syndrome without ST-segment elevation (NSTE-ACS) meeting the criteria of low risk with demostrated fall of cTn levels, or patients prepared for cardiac surgery.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Griva M, Stastny J, Kopriva P, Slabak M, Coufal Z, Jarkovsky J, Svoboda M, Salek T, Sukupova L, Taborsky M. Selective coronary angiography, percutaneous coronary intervention and asymptomatic peri-procedural myocardial injury. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Dec;163(4):324-330. doi: 10.5507/bp.2018.066. Epub 2018 Nov 6.

    PMID: 30398220DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Martin Griva, MD

    Cardiac Center for Adults, Tomas Bata Hospital, Zlin, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 9, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share