Troponin Release Induced by Procedure - Czech | NCT02960321

Studies
Troponin Release Induced by Procedure - Czech

NCT02960321

Sponsor

Tomas Bata Hospital, Czech Republic

Status

Completed

Last Update Posted

Jan 6, 2017Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Not provided

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 6, 2016

First Submission Date that Met QC Criteria

Nov 6, 2016

First Posted Date

Nov 9, 2016Estimated

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

Jan 4, 2017

Last Update Posted Date

Jan 6, 2017Estimated

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

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.

Detailed 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.

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

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAG without PCI		Diagnostic coronary angiography only
CAG with PCI		Diagnostic coronary angiography and subsequent percutaneous coronary intervention (PCI)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subclinical myocardial injury		up to 24 hours after procedure

Secondary Outcomes

Measure	Description	Time Frame
Postprocedural myocardial infarction		up to 24 hours after procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Griva, MD	Cardiac Center for Adults, Tomas Bata Hospital, Zlin, Czech Republic	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30398220	Derived	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.

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