Myocardial InfarctionCORAMIregNCT01642784
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by Fundacja Ośrodek Badań Medycznych at 8 sites in 2 countries.
Trial summary
Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Nov 2011to Jul 2013
- 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: Study population will comprise of approx. 200 patients (males and females) with the diagnosis of STEMI or NSTEMI and at least two independent critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients enrolled to the registry must meet all the eligibility criteria.
Who may be able to join
- Diagnosis of STEMI or NSTEMI (according to ESC 2007 definition)
- Over 18 years of age
- Presence of two critical lesions requiring PCI in IRA (LAD (left anterior descending), Cx (circumflex), RCA (right coronary artery)):
- Target/culprit lesion which requires immediate stenting (>50 - 100%) and
- Second critical lesion (70-90%).
Who cannot join
- Terminal illness with life expectancy less <1 year or active cancer disease,
- Pregnancy or possibility of pregnancy
- Second critical lesion in IRA >90% or occlusion
- Contraindications to PCI or/and stent implantation
- Con-current participation in another clinical study that did not meet its primary end-point
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Poland7 sites
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
Krakow, 30-693
Centrum Kardiologii Inwazyjnej GVM Carint
Ostrowiec Świętokrzyski, 27-400
Centrum Kardiologii Inwazyjnej GVM Carint
Oświecim, 32-600
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
Pińczów
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
Sanok, 38-500
Pracownia Hemodynamiki Szpital im. E. Szczeklika
Tarnów, 33-100
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
Warsaw, 02-097
Slovenia1 site
Departament of Cardiology, University Hospital, Ljubljana
Ljubljana
About this study
Official title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
Read the detailed description
CORAMI is a registry study addressing the issue of complete vs culprit-only PCI within infarct related artery in patients with ST-elevation and non-ST elevation myocardial infarction treated with interventional procedures.
The main objectives of the study include:
- gathering data on patients with at least two independent critical stenotic lesions in IRA (one of which is the culprit lesion) during index primary PCI for STEMI or NSTEMI (prevalence, characteristic, predisposing factors).
- comparing chosen treatment strategies for multiple lesion IRA
- comparison of complete vs. target lesion-only PCI in IRA in acute MI (myocardial infarction) patients.
The study clinical hypothesis is that stenting single critical - culprit lesion in multi-lesion IRA in MI patients during index PCI procedure is superior to stenting all critical lesions in IRA in terms of early treatment result and might be associated with less frequent periprocedural angiographic complications.
H0: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is less or equal to efficacy of stenting all critical lesions in IRA.
H1: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is greater than efficacy of stenting all critical lesions in IRA.
CORAMI Registry is a prospective, international (Poland, Slovenia), multicenter observational study with retrospective chart review which will be performed in experienced invasive facility centres with 24/7 PCI duty and continuous patient enrollment for 18 months (January 2011 - June 2012).
This study will collect data on all consecutive patients with STEMI and NSTEMI undergoing immediate coronary angiography which demonstrated at least two independent (requiring two stent platforms) critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients will be treated (multiple or single lesion stenting) according to local standard and operator's decision. Patient follow up phone call and/or visit (according to local protocols) will be performed at 12 months from enrollment if applicable by local standards.
- Conditions
- Myocardial Infarction
- Being tested
- Primary PCI of culprit lesion in IRA with drug eluting stent (DES), Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
- Keywords
- STEMI, NSTEMI, revascularization, stents
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCI of culprit lesion in IRA with drug eluting stent (DES)Device
Primary PCI of culprit lesion in IRA with drug eluting stent (DES)
Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DESDevice
Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
| Study group | Role | What they receive |
|---|---|---|
| Culprit lesion IRA revascularization | Culprit lesion IRA revascularization Receives: Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES) | |
| Complete IRA revascularization | Complete IRA revascularization Receives: Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death rates at 12-month clinical follow-up
Measured: At 12 months
Stent thrombosis
Rates of stent thrombosis at 12-month follow-up according to ARC definition
Measured: At 12 months
reMI (repeat myocardial infarctions)
Rates of reMI at 12 months
Measured: At 12 months
urgent TVR (target vessel revascularization) at 12 months
Rates of urgent TVR at 12 months
Measured: 12 months and at 12 months
Planned TVR
Rates of planned TVR (PCI + CABG) at 12 months
Measured: At 12 months
Secondary outcomes (4)
Angiographic complications
Immediate in-hospital angiographic complications (at least one or more of the following: distal embolisation, no-reflow, slow-flow, acute coronary artery occlusion, artery perforation, tamponade, dissection type B and above)
Measured: During hospitalization
Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))
Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)
Measured: During hospitalization and at 12 months
Complete contrast dose in ml
Complete contrast dose in ml
Measured: During hospitalization and at 12 months
Complete radiation dose in mGy
Complete radiation dose in mGy
Measured: During hospitalization and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacja Ośrodek Badań Medycznych
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogdan Januś, MD, PhD, Principal investigator, Pracownia Hemodynamiki Szpital im. E. Szczeklika
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642784
- Sponsor's protocol ID
- 2.0, 2011-11-24
- Acronym
- CORAMIreg
- Status last verified
- Jul 2013
- First submitted
- 25 Jun 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
- ClinicalTrials.gov ID
- NCT01642784
- Acronym / sponsor ID
- CORAMIreg / 2.0, 2011-11-24
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, NSTEMI, revascularization, stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundacja Ośrodek Badań MedycznychUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Jul 2012 (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.
Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
Detailed description
CORAMI is a registry study addressing the issue of complete vs culprit-only PCI within infarct related artery in patients with ST-elevation and non-ST elevation myocardial infarction treated with interventional procedures.
The main objectives of the study include:
- gathering data on patients with at least two independent critical stenotic lesions in IRA (one of which is the culprit lesion) during index primary PCI for STEMI or NSTEMI (prevalence, characteristic, predisposing factors).
- comparing chosen treatment strategies for multiple lesion IRA
- comparison of complete vs. target lesion-only PCI in IRA in acute MI (myocardial infarction) patients.
The study clinical hypothesis is that stenting single critical - culprit lesion in multi-lesion IRA in MI patients during index PCI procedure is superior to stenting all critical lesions in IRA in terms of early treatment result and might be associated with less frequent periprocedural angiographic complications.
H0: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is less or equal to efficacy of stenting all critical lesions in IRA.
H1: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is greater than efficacy of stenting all critical lesions in IRA.
CORAMI Registry is a prospective, international (Poland, Slovenia), multicenter observational study with retrospective chart review which will be performed in experienced invasive facility centres with 24/7 PCI duty and continuous patient enrollment for 18 months (January 2011 - June 2012).
This study will collect data on all consecutive patients with STEMI and NSTEMI undergoing immediate coronary angiography which demonstrated at least two independent (requiring two stent platforms) critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients will be treated (multiple or single lesion stenting) according to local standard and operator's decision. Patient follow up phone call and/or visit (according to local protocols) will be performed at 12 months from enrollment if applicable by local standards.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culprit lesion IRA revascularization | – | Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES)Culprit lesion IRA revascularization |
| Complete IRA revascularization | – | Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DESComplete IRA revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will comprise of approx. 200 patients (males and females) with the diagnosis of STEMI or NSTEMI and at least two independent critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients enrolled to the registry must meet all the eligibility criteria.
Key inclusion criteria (5 listed)
- Diagnosis of STEMI or NSTEMI (according to ESC 2007 definition)
- Over 18 years of age
- Presence of two critical lesions requiring PCI in IRA (LAD (left anterior descending), Cx (circumflex), RCA (right coronary artery)):
Key exclusion criteria (5 listed)
- Terminal illness with life expectancy less <1 year or active cancer disease,
- Pregnancy or possibility of pregnancy
- Second critical lesion in IRA >90% or occlusion
- Contraindications to PCI or/and stent implantation
- Con-current participation in another clinical study that did not meet its primary end-point
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 |
|---|---|---|
| Primary PCI of culprit lesion in IRA with drug eluting stent (DES)Primary PCI of culprit lesion in IRA with drug eluting stent (DES) | Device | Culprit lesion IRA revascularization |
| Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DESPrimary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES | Device | Complete IRA revascularization |
Primary outcome
Death
Time frame: At 12 months
Death rates at 12-month clinical follow-up
Stent thrombosis
Time frame: At 12 months
Rates of stent thrombosis at 12-month follow-up according to ARC definition
reMI (repeat myocardial infarctions)
Time frame: At 12 months
Rates of reMI at 12 months
urgent TVR (target vessel revascularization) at 12 months
Time frame: 12 months and at 12 months
Rates of urgent TVR at 12 months
Planned TVR
Time frame: At 12 months
Rates of planned TVR (PCI + CABG) at 12 months
4 secondary outcomes
Angiographic complications
Time frame: During hospitalization
Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))
Time frame: During hospitalization and at 12 months
Complete contrast dose in ml
Time frame: During hospitalization and at 12 months
Complete radiation dose in mGy
Time frame: During hospitalization and at 12 months
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 3 Jul 2013.
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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.
Bogdan Januś, MD, PhD principal investigator
Pracownia Hemodynamiki Szpital im. E. Szczeklika
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Fundacja Ośrodek Badań Medycznych at 8 sites in 2 countries.
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 5 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 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, Slovenia. 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?
Death (time frame: At 12 months). The study lists 5 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 3 Jul 2013.