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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
complete multivessel revascularization
stress echocardiography and revascularization if required
Sponsored by
Complexo Hospitalario Universitario de A Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, primary angioplasty, multivessel disease, stress echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Complejo Hospitalario Universitario A CorunaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

complete multivessel revascularization

stress echo guided revascularization

Arm Description

Outcomes

Primary Outcome Measures

Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure

Secondary Outcome Measures

Incidence of acute renal failure (contrast induced nephropathy)
Cost analysis of both strategies
Death
cardiovascular death
re-myocardial infarction
revascularization of any vessel
admission due to heart failure

Full Information

First Posted
August 10, 2010
Last Updated
September 2, 2013
Sponsor
Complexo Hospitalario Universitario de A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT01179126
Brief Title
Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease
Acronym
CROSS-AMI
Official Title
Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complexo Hospitalario Universitario de A Coruña

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Echocardiography, Stress
Keywords
myocardial infarction, primary angioplasty, multivessel disease, stress echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
complete multivessel revascularization
Arm Type
Experimental
Arm Title
stress echo guided revascularization
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
complete multivessel revascularization
Intervention Description
After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission
Intervention Type
Procedure
Intervention Name(s)
stress echocardiography and revascularization if required
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure
Time Frame
one year
Secondary Outcome Measure Information:
Title
Incidence of acute renal failure (contrast induced nephropathy)
Time Frame
Admission
Title
Cost analysis of both strategies
Time Frame
1 year
Title
Death
Description
cardiovascular death
Time Frame
one year
Title
re-myocardial infarction
Time Frame
one year
Title
revascularization of any vessel
Time Frame
one year
Title
admission due to heart failure
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Estevez-Loureiro, MD
Phone
981 17 80 31
Email
Rodrigo.Estevez.Loureiro@sergas.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Estevez-Loureiro, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario Universitario A Couna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon Calvino-Santos, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicolas Vazquez-Gonzalez, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jorge Salgado-Fernandez, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pablo Pinon-Esteban, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guillermo Aldama-Lopez, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xacobe Flores-Rios, MD
Organizational Affiliation
Interventional Cardiology. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jesus Peteiro, MD, PhD
Organizational Affiliation
Stress Echo Unit. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alberto Bouzas-Mosquera, MD
Organizational Affiliation
Stress Echo Unit. Complejo Hospitalario A Couna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose Angel Rodriguez-Fernandez, MD
Organizational Affiliation
Coronary Care Unit. Complejo Hospitalario A Couna
Official's Role
Study Chair
Facility Information:
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Estevez-Loureiro, MD
Phone
+34 981 178034
Email
Rodrigo.Estevez.Loureiro@sergas.es
First Name & Middle Initial & Last Name & Degree
Rodrigo Estevez-Loureiro, MD
First Name & Middle Initial & Last Name & Degree
Ramon Calvino-Santos, MD
First Name & Middle Initial & Last Name & Degree
Nicolas Vazquez-Gonzalez, MD
First Name & Middle Initial & Last Name & Degree
Pablo Pinon-Esteban, MD
First Name & Middle Initial & Last Name & Degree
Guillermo Aldama-Lopez, MD
First Name & Middle Initial & Last Name & Degree
Jorge Salgado-Fernandez, MD
First Name & Middle Initial & Last Name & Degree
Xacobe Flores-Rios, MD
First Name & Middle Initial & Last Name & Degree
Jesus Peteiro, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alberto Bouzas-Mosquera, MD
First Name & Middle Initial & Last Name & Degree
Jose Angel Rodriguez-Fernandez, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33257214
Citation
Flores-Rios X, Calvino-Santos RA, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Marzoa-Rivas R, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Vazquez-Gonzalez N, Muniz-Garcia J, Vazquez-Rodriguez JM. Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1054-1061. doi: 10.1016/j.rec.2020.09.028. Epub 2020 Nov 27. English, Spanish.
Results Reference
derived
PubMed Identifier
31554422
Citation
Calvino-Santos R, Estevez-Loureiro R, Peteiro-Vazquez J, Salgado-Fernandez J, Rodriguez-Vilela A, Franco-Gutierrez R, Bouzas-Mosquera A, Rodriguez-Fernandez JA, Mesias-Prego A, Gonzalez-Juanatey C, Aldama-Lopez G, Pinon-Esteban P, Flores-Rios X, Soler-Martin R, Seoane-Pillado T, Vazquez-Gonzalez N, Muniz J, Vazquez-Rodriguez JM. Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial. Circ Cardiovasc Interv. 2019 Oct;12(10):e007924. doi: 10.1161/CIRCINTERVENTIONS.119.007924. Epub 2019 Sep 26.
Results Reference
derived

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

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