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

This study is currently recruiting participants.
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

August 10, 2010
September 2, 2013
September 2010
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01179126 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myocardial Infarction
  • Angioplasty, Transluminal, Percutaneous Coronary
  • Echocardiography, Stress
  • 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.
  • Experimental: complete multivessel revascularization
    Intervention: Procedure: complete multivessel revascularization
  • Active Comparator: stress echo guided revascularization
    Intervention: Procedure: stress echocardiography and revascularization if required
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rodrigo Estevez-Loureiro, MD 981 17 80 31 Rodrigo.Estevez.Loureiro@sergas.es
Spain
 
NCT01179126
CROSS-AMI
No
Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña
Complexo Hospitalario Universitario de A Coruña
Not Provided
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
Complexo Hospitalario Universitario de A Coruña
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP