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

NCT01179126 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-09-04

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Complexo Hospitalario Universitario de A Coruña

    lead OTHER

Principal Investigators

  • Rodrigo Estevez-Loureiro, MD · Interventional Cardiology. Complejo Hospitalario Universitario A Couna

  • Ramon Calvino-Santos, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Nicolas Vazquez-Gonzalez, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Jorge Salgado-Fernandez, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Pablo Pinon-Esteban, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Guillermo Aldama-Lopez, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Xacobe Flores-Rios, MD · Interventional Cardiology. Complejo Hospitalario A Couna

  • Jesus Peteiro, MD, PhD · Stress Echo Unit. Complejo Hospitalario A Couna

  • Alberto Bouzas-Mosquera, MD · Stress Echo Unit. Complejo Hospitalario A Couna

  • Jose Angel Rodriguez-Fernandez, MD · Coronary Care Unit. Complejo Hospitalario A Couna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-09-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179126 on ClinicalTrials.gov