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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179126
First Posted: August 11, 2010
Last Update Posted: September 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rodrigo Estévez-Loureiro, Complexo Hospitalario Universitario de A Coruña
August 10, 2010
August 11, 2010
September 4, 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 ]
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 ]
  • Cost analysis of both strategies [ Time Frame: 1 year ]
  • Death [ Time Frame: one year ]
    cardiovascular death
  • re-myocardial infarction [ Time Frame: one year ]
  • revascularization of any vessel [ Time Frame: one year ]
  • admission due to heart failure [ Time Frame: one year ]
  • Incidence of acute renal failure (contrast induced nephropathy) [ Time Frame: Admission ]
  • Cost analysis of both strategies [ Time Frame: 1 year ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01179126
CROSS-AMI
No
Not Provided
Not Provided
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