Myocardial InfarctionMVDNCT02756000
Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI
A study testing PCI and dobutamine stress echocardiography in people with Myocardial Infarction, run by Clinical Hospital Center Zemun at 4 sites in Serbia.
Trial summary
The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- PCI and dobutamine stress echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesSerbia
- Study dates
- Jan 2016to Nov 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording)
- Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels
- Treated with primary PCI of infarct related artery (IRA) only.
Who cannot join
- Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI;
- Presence of significant valvular disease;
- Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI;
- Myocardial infarction is caused by stent thrombosis:
- Chronic total occlusion of any of the coronary arteries on initial angiogram;
- Previously treated by CABG surgery;
- Estimated life expectancy less than one year.
Trial locations and contacts
4 sites in 1 country.
Serbia4 sites
Military Medical Academy
Belgrade, 11000
Clinical Hospital Center Zemun
Belgrade, 11080
Clinical Center Kragujevac
Kragujevac, 34000
Institute for cardiovascular diseases Vojvodine
Novi Sad, 21000
About this study
Official title: Appropriate Timing of Complete Revascularization for Multivessel Coronary Artery Disease After Culprit Only Primary Percutaneous Coronary Intervention (PCI) for ST Elevation Myocardial Infarction
The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.
Read the detailed description
This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.
- Conditions
- Myocardial Infarction
- Being tested
- PCI, dobutamine stress echocardiography
- Keywords
- myocardial infarction, percutaneous coronary intervention, multivessel coronary artery disease, dobutamine stress echocardiography
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called percutaneous coronary intervention
percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
dobutamine stress echocardiographyProcedure or surgery
Echocardiographic stress test of provoked myocardial ischemia using dobutamine
| Study group | Role | What they receive |
|---|---|---|
| complete PCI at initial hospitalization | Experimental | Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction Receives: Procedure: PCI |
| complete PCI after 30 days | Experimental | Staged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction Receives: Procedure: PCI |
| Dobutamine stress testing | Active comparator | Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography Receives: Procedure: PCI; Procedure: dobutamine stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardio-cerebral events
cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization
Measured: one year
Secondary outcomes (5)
cardiac death
Occurence of death caused by cardiac condition
Measured: one year
repeated myocardial infarction
Occurrence of repeated myocardial infarction in the study groups
Measured: one year
complications of percutaneous coronary intervention
Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events
Measured: one year
stent thrombosis
Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria
Measured: two years
hospitalization for heart failure
Occurrence of hospitalization for heart failure in the study groups
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Zemun
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cardiovascular Diseases, Vojvodina, Military Medical Academy, Belgrade, Serbia, Clinical Center Kragujevac
- Responsible party
- Principal investigator, Ivan Ilic, Clinical Hospital Center Zemun
- Investigators
- Aleksandar N Neskovic, MD, PhD, Study chair, Clinical Hospital Center Zemun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756000
- Sponsor's protocol ID
- ZEM-CARD-003
- Acronym
- MVD
- Status last verified
- Jun 2023
- First submitted
- 28 Apr 2016
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Timing of Complete Revascularization for Multivessel Coronary Artery Disease After Culprit Only Primary Percutaneous Coronary Intervention (PCI) for ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02756000
- Acronym / sponsor ID
- MVD / ZEM-CARD-003
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, percutaneous coronary intervention, multivessel coronary artery disease, dobutamine stress echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Clinical Hospital Center ZemunUniversity, hospital or other
- Collaborators
- Institute of Cardiovascular Diseases, Vojvodina, Military Medical Academy, Belgrade, Serbia, Clinical Center Kragujevac
- Study start
- Jan 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 29 Apr 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.
The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.
Detailed description
This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| complete PCI at initial hospitalization | Experimental | Procedure: PCIStaged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction |
| complete PCI after 30 days | Experimental | Procedure: PCIStaged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction |
| Dobutamine stress testing | Active comparator | Procedure: PCI, Procedure: dobutamine stress echocardiographyRevascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording)
- Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels
- Treated with primary PCI of infarct related artery (IRA) only.
Key exclusion criteria (7 listed)
- Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI;
- Presence of significant valvular disease;
- Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI;
- Myocardial infarction is caused by stent thrombosis:
- Chronic total occlusion of any of the coronary arteries on initial angiogram;
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 |
|---|---|---|
| PCIAlso: percutaneous coronary interventionpercutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis | Procedure or surgery | Dobutamine stress testing, complete PCI after 30 days, complete PCI at initial hospitalization |
| dobutamine stress echocardiographyEchocardiographic stress test of provoked myocardial ischemia using dobutamine | Procedure or surgery | Dobutamine stress testing |
Primary outcome
major adverse cardio-cerebral events
Time frame: one year
cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization
5 secondary outcomes
cardiac death
Time frame: one year
repeated myocardial infarction
Time frame: one year
complications of percutaneous coronary intervention
Time frame: one year
stent thrombosis
Time frame: two years
hospitalization for heart failure
Time frame: one year
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 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Aleksandar N Neskovic, MD, PhD study chair
Clinical Hospital Center Zemun
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI and dobutamine stress echocardiography in people with Myocardial Infarction, run by Clinical Hospital Center Zemun at 4 sites in Serbia.
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 3 inclusion and 7 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Serbia. 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?
major adverse cardio-cerebral events (time frame: one year). 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 2 Jun 2023.