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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Complexo Hospitalario Universitario de A Coruña
Sponsor:
Information provided by (Responsible Party):
Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier:
NCT01179126
First received: August 10, 2010
Last updated: September 2, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Complexo Hospitalario Universitario de A Coruña:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179126

Contacts
Contact: Rodrigo Estevez-Loureiro, MD 981 17 80 31 Rodrigo.Estevez.Loureiro@sergas.es

Locations
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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Rodrigo Estévez-Loureiro, MD, PhD, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT01179126     History of Changes
Other Study ID Numbers: CROSS-AMI
Study First Received: August 10, 2010
Last Updated: September 2, 2013
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014