Coronary Artery DiseaseTRIP-CZNCT02960321
Troponin Release Induced by Procedure - Czech
An observational study of Coronary Artery Disease, run by Tomas Bata Hospital, Czech Republic.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- acute coronary syndrome with persistent ST-segment elevation
- acute coronary syndrome without ST-segment elevation meeting the criteria of high or intermediate risk
About this study
Official title: Myocardial Injury Related to Coronary Angiography in the Era of High-sensitivity Cardiac Troponin I
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial injury, high-sensitivity troponin I, periprocedural myocardial infarction
- 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 |
|---|---|---|
| CAG without PCI | Diagnostic coronary angiography only | |
| CAG with PCI | Diagnostic coronary angiography and subsequent percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical myocardial injury
Measured: up to 24 hours after procedure
Secondary outcomes (1)
Postprocedural myocardial infarction
Measured: up to 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Griva, MD, Principal investigator, Cardiac Center for Adults, Tomas Bata Hospital, Zlin, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960321
- Sponsor's protocol ID
- BN112016
- Acronym
- TRIP-CZ
- Status last verified
- Jan 2017
- First submitted
- 6 Nov 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30398220
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Injury Related to Coronary Angiography in the Era of High-sensitivity Cardiac Troponin I
- ClinicalTrials.gov ID
- NCT02960321
- Acronym / sponsor ID
- TRIP-CZ / BN112016
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial injury, high-sensitivity troponin I, periprocedural myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Nov 2016 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAG without PCI | – | –Diagnostic coronary angiography only |
| CAG with PCI | – | –Diagnostic coronary angiography and subsequent percutaneous coronary intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- acute coronary syndrome with persistent ST-segment elevation
- acute coronary syndrome without ST-segment elevation meeting the criteria of high or intermediate risk
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
Subclinical myocardial injury
Time frame: up to 24 hours after procedure
1 secondary outcome
Postprocedural myocardial infarction
Time frame: up to 24 hours after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 30398220Griva 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.
- Individual participant dataSharing planned: No
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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.
Martin Griva, MD principal investigator
Cardiac Center for Adults, Tomas Bata Hospital, Zlin, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Tomas Bata Hospital, Czech Republic.
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 2 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: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subclinical myocardial injury (time frame: up to 24 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960321, which also lists 1 linked publication.
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 6 Jan 2017.