Myocardial InfarctionPhase 3CROSS-AMINCT01179126
Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease
A Phase 3 study testing complete multivessel revascularization and stress echocardiography and revascularization if required in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
Trial summary
Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Echocardiography, Stress
- What is being tested?
- complete multivessel revascularization and stress echocardiography and revascularization if required
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2010to Sep 2014
- Phase
- Phase 3
- 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
- Typical chest pain lasting >30 minutes with ST-segment elevation >=1mm in >=2 contiguous ECG leads or left bundle branch block and presentation < 48 hours since symptom onset.
- Patients undergoing rescue PCI
- Patients with effective lysis and coronary angiography in less than 24 hours
- Presence of other lesion >=70% in a non-culprit artery.
- Informed consent
Who cannot join
- Significant left main disease
- Lesions in vessels < 2 mm
- Lesions in branches of a main epicardial coronary artery and short irrigation territory
- Previous coronary artery bypass graft (CABG)
- Any coronary intervention in the previous month
- Cardiogenic shock
- Anatomic features no suitable for coronary intervention
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna
A Coruña, A Coruna, 15006
Rodrigo Estevez-Loureiro, MD, +34 981 178034, Rodrigo.Estevez.Loureiro@sergas.es
Rodrigo Estevez-Loureiro, MD
About this study
Official title: Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction
Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice.
To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results.
Read more
Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence.
Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.
- Conditions
- Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Echocardiography, Stress
- Being tested
- complete multivessel revascularization, stress echocardiography and revascularization if required
- Keywords
- myocardial infarction, primary angioplasty, multivessel disease, 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.
complete multivessel revascularizationProcedure or surgery
After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission
stress echocardiography and revascularization if requiredProcedure or surgery
after successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized.
| Study group | Role | What they receive |
|---|---|---|
| complete multivessel revascularization | Experimental | Not described Receives: Procedure: complete multivessel revascularization |
| stress echo guided revascularization | Active comparator | Not described Receives: Procedure: stress echocardiography and revascularization if required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure
Measured: one year
Secondary outcomes (6)
Incidence of acute renal failure (contrast induced nephropathy)
Measured: Admission
Cost analysis of both strategies
Measured: 1 year
Death
cardiovascular death
Measured: one year
re-myocardial infarction
Measured: one year
revascularization of any vessel
Measured: one year
admission due to heart failure
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 posted11 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña
- Investigators
- Rodrigo Estevez-Loureiro, MD, Principal investigator, Interventional Cardiology. Complejo Hospitalario Universitario A CounaRamon Calvino-Santos, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaNicolas Vazquez-Gonzalez, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaJorge Salgado-Fernandez, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaPablo Pinon-Esteban, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaGuillermo Aldama-Lopez, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaXacobe Flores-Rios, MD, Study chair, Interventional Cardiology. Complejo Hospitalario A CounaJesus Peteiro, MD, PhD, Study chair, Stress Echo Unit. Complejo Hospitalario A Couna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179126
- Sponsor's protocol ID
- CROSS-AMI
- Acronym
- CROSS-AMI
- Status last verified
- Sep 2013
- First submitted
- 10 Aug 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Flores-Rios X, Calvino-Santos RA, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Marzoa-Rivas R, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Vazquez-Gonzalez N, Muniz-Garcia J, Vazquez-Rodriguez JM. Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1054-1061. doi: 10.1016/j.rec.2020.09.028. Epub 2020 Nov 27. English, Spanish.
PubMed 33257214Calvino-Santos R, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Mesias-Prego A, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Flores-Rios X, Soler-Martin R, Seoane-Pillado T, Vazquez-Gonzalez N, Muniz J, Vazquez-Rodriguez JM. Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial. Circ Cardiovasc Interv. 2019 Oct;12(10):e007924. doi: 10.1161/CIRCINTERVENTIONS.119.007924. Epub 2019 Sep 26.
PubMed 31554422
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01179126
- Acronym / sponsor ID
- CROSS-AMI / CROSS-AMI
- Conditions
- Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Echocardiography, Stress
- Keywords
- myocardial infarction, primary angioplasty, multivessel disease, stress echocardiography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (estimated)
- First posted
- 11 Aug 2010 (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.
Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice.
To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results.
Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence.
Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete multivessel revascularization | Experimental | Procedure: complete multivessel revascularization |
| stress echo guided revascularization | Active comparator | Procedure: stress echocardiography and revascularization if required |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Typical chest pain lasting >30 minutes with ST-segment elevation >=1mm in >=2 contiguous ECG leads or left bundle branch block and presentation < 48 hours since symptom onset.
- Patients undergoing rescue PCI
- Patients with effective lysis and coronary angiography in less than 24 hours
- Presence of other lesion >=70% in a non-culprit artery.
- Informed consent
Key exclusion criteria (8 listed)
- Significant left main disease
- Lesions in vessels < 2 mm
- Lesions in branches of a main epicardial coronary artery and short irrigation territory
- Previous coronary artery bypass graft (CABG)
- Any coronary intervention in the previous month
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 |
|---|---|---|
| complete multivessel revascularizationAfter a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission | Procedure or surgery | complete multivessel revascularization |
| stress echocardiography and revascularization if requiredafter successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized. | Procedure or surgery | stress echo guided revascularization |
Primary outcome
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure
Time frame: one year
6 secondary outcomes
Incidence of acute renal failure (contrast induced nephropathy)
Time frame: Admission
Cost analysis of both strategies
Time frame: 1 year
Death
Time frame: one year
re-myocardial infarction
Time frame: one year
revascularization of any vessel
Time frame: one year
admission due to heart failure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 33257214Flores-Rios X, Calvino-Santos RA, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Marzoa-Rivas R, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Vazquez-Gonzalez N, Muniz-Garcia J, Vazquez-Rodriguez JM. Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1054-1061. doi: 10.1016/j.rec.2020.09.028. Epub 2020 Nov 27. English, Spanish.
- Derived from this study: PubMed 31554422Calvino-Santos R, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Mesias-Prego A, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Flores-Rios X, Soler-Martin R, Seoane-Pillado T, Vazquez-Gonzalez N, Muniz J, Vazquez-Rodriguez JM. Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial. Circ Cardiovasc Interv. 2019 Oct;12(10):e007924. doi: 10.1161/CIRCINTERVENTIONS.119.007924. Epub 2019 Sep 26.
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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.
Rodrigo Estevez-Loureiro, MD principal investigator
Interventional Cardiology. Complejo Hospitalario Universitario A Couna
Ramon Calvino-Santos, MD study chair
Interventional Cardiology. Complejo Hospitalario A Couna
Nicolas Vazquez-Gonzalez, MD study chair
Interventional Cardiology. Complejo Hospitalario A Couna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing complete multivessel revascularization and stress echocardiography and revascularization if required in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 4 Sep 2013. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Estevez-Loureiro, MD (981 17 80 31, Rodrigo.Estevez.Loureiro@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure (time frame: one year). 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 NCT01179126, which also lists 2 linked publications.
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 4 Sep 2013.