Coronary Artery StenosisPrague-13NCT01332591
Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
A study testing Percutaneous coronary intervention in people with Coronary Artery Stenosis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2008to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- Patient with acute myocardial infarction with ST segment elevation (STEMI)
- Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
- One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
- Enrollment ≥48 hours following onset of symptoms
Who cannot join
- Stenosis of the left main of left coronary artery ≥ 50%
- Hemodynamically significant valvular disease
- Patients in cardiogenic shock during STEMI
- Hemodynamic instability
- Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Cardioangiology, St. Anne University Hospital
Brno, 65691
About this study
Official title: Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Read the detailed description
Introduction:
Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.
Aim of study:
The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Hypothesis:
Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.
- Conditions
- Coronary Artery Stenosis
- Being tested
- Percutaneous coronary intervention
- Keywords
- STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
- Medical subject headings
- Coronary Stenosis, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
PCI of significant stenoses of "non-infarct" coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| Complete revascularization | Active comparator | Percutaneous coronary intervention of "non-infarct" coronary arteries Receives: Procedure: Percutaneous coronary intervention |
| Conservative management | No intervention | standard guideline-based medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of death, nonfatal acute myocardial infarction and stroke
Measured: 2 years
Secondary outcomes (10)
cardiovascular death
Measured: 2 years
recurrent myocardial infarction
Measured: 2 years
target vessel failure
progression of studied stenosis of non-culprit artery
Measured: 2 years
stroke
Measured: 2 years
hospitalization for heart failure
Measured: 2 years
changes of left ventricular ejection fraction
Measured: 2 years
hospitalization for unstable angina pectoris
Measured: 2 years
outcomes of questionnaire regarding angina pectoris
Measured: 2 years
target vessel revascularization
non infarct artery
Measured: 2 years
target lesion revascularization
non infarct artery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Bulgarian Cardiac Institute, Tomas Bata Hospital, Czech Republic
- Responsible party
- Principal investigator, Ota Hlinomaz, MD, PhD, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Ota Hlinomaz, MD, PhD, Principal investigator, +420604273627
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332591
- Sponsor's protocol ID
- NT11412
- Acronym
- Prague-13
- Status last verified
- Dec 2014
- First submitted
- 30 Mar 2011
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
- ClinicalTrials.gov ID
- NCT01332591
- Acronym / sponsor ID
- Prague-13 / NT11412
- Conditions
- Coronary Artery Stenosis
- Keywords
- STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Bulgarian Cardiac Institute, Tomas Bata Hospital, Czech Republic
- Study start
- Sep 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 2011 (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.
The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Detailed description
Introduction:
Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.
Aim of study:
The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Hypothesis:
Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete revascularization | Active comparator | Procedure: Percutaneous coronary interventionPercutaneous coronary intervention of "non-infarct" coronary arteries |
| Conservative management | No intervention | –standard guideline-based medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with acute myocardial infarction with ST segment elevation (STEMI)
- Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
- One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
- Enrollment ≥48 hours following onset of symptoms
Key exclusion criteria (5 listed)
- Stenosis of the left main of left coronary artery ≥ 50%
- Hemodynamically significant valvular disease
- Patients in cardiogenic shock during STEMI
- Hemodynamic instability
- Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionPCI of significant stenoses of "non-infarct" coronary arteries | Procedure or surgery | Complete revascularization |
Primary outcome
composite endpoint of death, nonfatal acute myocardial infarction and stroke
Time frame: 2 years
10 secondary outcomes
cardiovascular death
Time frame: 2 years
recurrent myocardial infarction
Time frame: 2 years
target vessel failure
Time frame: 2 years
stroke
Time frame: 2 years
hospitalization for heart failure
Time frame: 2 years
changes of left ventricular ejection fraction
Time frame: 2 years
hospitalization for unstable angina pectoris
Time frame: 2 years
outcomes of questionnaire regarding angina pectoris
Time frame: 2 years
target vessel revascularization
Time frame: 2 years
target lesion revascularization
Time frame: 2 years
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 1 Jan 2015.
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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.
Ota Hlinomaz, MD, PhD principal investigator
+420604273627
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Stenosis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 4 inclusion and 5 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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
composite endpoint of death, nonfatal acute myocardial infarction and stroke (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2015.