Salvage of Myocardial Infarction Documented by MRI in Patients Undergoing Rescue Percutaneous Coronary Intervention (SAVEME)

February 12, 2019 updated by: Luiz Fernando Ybarra, Federal University of São Paulo

Salvage of Myocardial Infarction Documented by Magnetic Resonance Imaging in Patients Undergoing Rescue Percutaneous Coronary Intervention

Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Rescue angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. The development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. This is an important information that can help understand which cases benefit most from rescue angioplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Escola Paulista de Medicina - Universidade Federal de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ST segment elevation myocardial infarction (STEMI) who underwent Thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (EKG) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (PCI).

Exclusion Criteria:

  • Patients with contraindication to Cardiac Magnetic Resonance Imaging (MRI) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc).
  • Allergy or contraindication to Gadolinium.
  • Contraindication to dual anti-platelet therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Magnetic Resonance Imaging
Cardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months.
Device: Cardiac Magnetic Resonance Imaging
7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Infarct size - percentage of left ventricular mass with signal intensity 2 standard deviations above the mean signal obtained in the remote non-infarcted myocardium.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Chair: Antonio C Carvalho, MD, PhD, Full Professor at Universidade Federal de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 518.844

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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