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

Myocardial Infarction Clinical Trial

— CROSS-AMI  

Official title:

Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01179126
• Other study ID #: CROSS-AMI
• Status: Recruiting
• Phase: Phase 3
• First received: August 10, 2010
• Last updated: September 2, 2013
• Start date: September 2010

Study information

• Verified date: September 2013
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: Rodrigo Estevez-Loureiro, MD
• Phone: 981 17 80 31
• Email: Rodrigo.Estevez.Loureiro[@]sergas.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Echocardiography, Stress
• Infarction
• Myocardial Infarction

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna

Sponsors (1)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure		one year	No
Secondary	Incidence of acute renal failure (contrast induced nephropathy)		Admission	Yes
Secondary	Cost analysis of both strategies		1 year	No
Secondary	Death	cardiovascular death	one year	Yes
Secondary	re-myocardial infarction		one year	No
Secondary	revascularization of any vessel		one year	No
Secondary	admission due to heart failure		one year	No