STEMIPromiseNCT04582175
Comparison Between Two Revascularization Strategies in MVD Patients With Uncomplicated ST-elevation MI
An observational study of STEMI, run by University of Oradea at 1 site in Romania.
Trial summary
The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- STEMI
- What is being tested?
- angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jul 2020to 5 Sep 2020
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: multivessel patients with STEMI uncomplicated by cardiogenic shock
Who may be able to join
- Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.
- Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- At least 75% diameter stenosis (visual estimation) or
- At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
- Age between 18 and 90 years
- Written informed consent could be obtained from all the patients
Who cannot join
- Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
- Cardiogenic shock
- Non-cardiovascular known co-morbidity reducing life expectancy to < 2 years
- Any factor precluding 1year follow-up
- Prior Coronary Artery Bypass Graft (CABG) Surgery
- A different operator from the previously designated
- Unable to provide consent for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, One Center Comparison of Outcomes Between Complete Revascularization by PCI at the Time of PPCI or During the Index Hospital Admission in One Hundred MVD Patients With ST-elevation MI Uncomplicated by Cardiogenic Shock
The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.
Read the detailed description
Complete revascularisation in MVD patients with STEMI uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. The 2018 ESC/EACTS Guidelines on myocardial revascularization states that "routine revascularization of non-IRA (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". Our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions PCI during PPCI or during the same hospital admission.
- Conditions
- STEMI
- Being tested
- angioplasty
- Keywords
- PPCI, multivessel coronary artery disease, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplastyProcedure or surgery
angioplasty of all non-culprit lesions
| Study group | Role | What they receive |
|---|---|---|
| group A | patients who received complete revascularization by angioplasty during the PPCI Receives: Procedure: angioplasty | |
| Group B | patients who underwent complete revascularization by angioplasty in a staged procedure Receives: Procedure: angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year all-cause mortality
death at one year
Measured: one year
MACCE at one year
major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction
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 posted9 Oct 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oradea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nichita-Brendea Mihnea-Traian, University of Oradea
- Investigators
- Mihnea-Traian T Nichita-Brendea, MD, Principal investigator, Spitalul Clinic Judetean de Urgenta Oradea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582175
- Sponsor's protocol ID
- Uoradea
- Acronym
- Promise
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, One Center Comparison of Outcomes Between Complete Revascularization by PCI at the Time of PPCI or During the Index Hospital Admission in One Hundred MVD Patients With ST-elevation MI Uncomplicated by Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT04582175
- Acronym / sponsor ID
- Promise / Uoradea
- Conditions
- STEMI
- Keywords
- PPCI, multivessel coronary artery disease, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OradeaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 9 Oct 2020 (actual)
- 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 aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.
Detailed description
Complete revascularisation in MVD patients with STEMI uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. The 2018 ESC/EACTS Guidelines on myocardial revascularization states that "routine revascularization of non-IRA (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". Our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions PCI during PPCI or during the same hospital admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: angioplastypatients who received complete revascularization by angioplasty during the PPCI |
| Group B | – | Procedure: angioplastypatients who underwent complete revascularization by angioplasty in a staged procedure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- multivessel patients with STEMI uncomplicated by cardiogenic shock
Key inclusion criteria (6 listed)
- Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.
- Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- Age between 18 and 90 years
- Written informed consent could be obtained from all the patients
Key exclusion criteria (7 listed)
- Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
- Cardiogenic shock
- Non-cardiovascular known co-morbidity reducing life expectancy to < 2 years
- Any factor precluding 1year follow-up
- Prior Coronary Artery Bypass Graft (CABG) Surgery
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 |
|---|---|---|
| angioplastyangioplasty of all non-culprit lesions | Procedure or surgery | Group B, group A |
Primary outcome
one year all-cause mortality
Time frame: one year
death at one year
MACCE at one year
Time frame: one year
major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction
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 9 Oct 2020.
- 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.
Mihnea-Traian T Nichita-Brendea, MD principal investigator
Spitalul Clinic Judetean de Urgenta Oradea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by University of Oradea at 1 site in Romania.
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 6 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 9 Oct 2020. 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 Romania. 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?
one year all-cause mortality (time frame: one year). The study lists 2 primary outcomes in all. 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 9 Oct 2020.