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

September 2, 2013 updated by: Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • A Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute renal failure (contrast induced nephropathy)
Time Frame: Admission
Admission
Cost analysis of both strategies
Time Frame: 1 year
1 year
Death
Time Frame: one year
cardiovascular death
one year
re-myocardial infarction
Time Frame: one year
one year
revascularization of any vessel
Time Frame: one year
one year
admission due to heart failure
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROSS-AMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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