Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease (CROSS-AMI)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Angioplasty, Transluminal, Percutaneous Coronary Echocardiography, Stress |
Procedure: complete multivessel revascularization Procedure: stress echocardiography and revascularization if required |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction |
- Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of acute renal failure (contrast induced nephropathy) [ Time Frame: Admission ] [ Designated as safety issue: Yes ]
- Cost analysis of both strategies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Death [ Time Frame: one year ] [ Designated as safety issue: Yes ]cardiovascular death
- re-myocardial infarction [ Time Frame: one year ] [ Designated as safety issue: No ]
- revascularization of any vessel [ Time Frame: one year ] [ Designated as safety issue: No ]
- admission due to heart failure [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: complete multivessel revascularization |
Procedure: complete multivessel revascularization
After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission
|
| Active Comparator: stress echo guided revascularization |
Procedure: stress echocardiography and revascularization if required
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Rodrigo Estevez-Loureiro, MD | 981 17 80 31 | Rodrigo.Estevez.Loureiro@sergas.es |
| Spain | |
| Complejo Hospitalario Universitario A Coruna | Recruiting |
| A Coruna, Spain, 15006 | |
| Contact: Rodrigo Estevez-Loureiro, MD +34 981 178034 Rodrigo.Estevez.Loureiro@sergas.es | |
| Principal Investigator: Rodrigo Estevez-Loureiro, MD | |
| Sub-Investigator: Ramon Calvino-Santos, MD | |
| Sub-Investigator: Nicolas Vazquez-Gonzalez, MD | |
| Sub-Investigator: Pablo Pinon-Esteban, MD | |
| Sub-Investigator: Guillermo Aldama-Lopez, MD | |
| Sub-Investigator: Jorge Salgado-Fernandez, MD | |
| Sub-Investigator: Xacobe Flores-Rios, MD | |
| Sub-Investigator: Jesus Peteiro, MD, PhD | |
| Sub-Investigator: Alberto Bouzas-Mosquera, MD | |
| Sub-Investigator: Jose Angel Rodriguez-Fernandez, MD | |
| Principal Investigator: | Rodrigo Estevez-Loureiro, MD | Interventional Cardiology. Complejo Hospitalario Universitario A Couna |
| Study Chair: | Ramon Calvino-Santos, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Nicolas Vazquez-Gonzalez, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Jorge Salgado-Fernandez, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Pablo Pinon-Esteban, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Guillermo Aldama-Lopez, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Xacobe Flores-Rios, MD | Interventional Cardiology. Complejo Hospitalario A Couna |
| Study Chair: | Jesus Peteiro, MD, PhD | Stress Echo Unit. Complejo Hospitalario A Couna |
| Study Chair: | Alberto Bouzas-Mosquera, MD | Stress Echo Unit. Complejo Hospitalario A Couna |
| Study Chair: | Jose Angel Rodriguez-Fernandez, MD | Coronary Care Unit. Complejo Hospitalario A Couna |
More Information
No publications provided
| Responsible Party: | Rodrigo Estevez-Loureiro, Complexo Hospitalario Universitario de A Couna |
| ClinicalTrials.gov Identifier: | NCT01179126 History of Changes |
| Other Study ID Numbers: | CROSS-AMI |
| Study First Received: | August 10, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Complexo Hospitalario Universitario de A Coruña:
|
myocardial infarction primary angioplasty multivessel disease stress echocardiography |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
