Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease

NCT01179126 | Unknown Phase 3

• 1 other identifier: CROSS-AMI
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Echocardiography, Stress

Keywords

myocardial infarction; primary angioplasty; multivessel disease; stress echocardiography

Outcome Measures

Primary Outcomes (1)

• Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure

  one year

Secondary Outcomes (6)

• Incidence of acute renal failure (contrast induced nephropathy)

  Admission

• Cost analysis of both strategies

  1 year

• Death

  one year

• re-myocardial infarction

  one year

• revascularization of any vessel

  one year

Study Arms (2)

complete multivessel revascularization

EXPERIMENTAL

Procedure: complete multivessel revascularization

stress echo guided revascularization

ACTIVE COMPARATOR

Procedure: stress echocardiography and revascularization if required

Interventions

complete multivessel revascularization PROCEDURE

After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission

complete multivessel revascularization

stress echocardiography and revascularization if required PROCEDURE

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.

stress echo guided revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña: lead

Study Sites (1)

Complejo Hospitalario Universitario A Coruna

A Coruña, A Coruna, 15006, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 33257214 DERIVED

• Calvino-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.

  PMID: 31554422 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rodrigo Estevez-Loureiro, MD

  Interventional Cardiology. Complejo Hospitalario Universitario A Couna

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Rodrigo Estevez-Loureiro, MD

CONTACT

981 17 80 31; Rodrigo.Estevez.Loureiro@sergas.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

ES (1)