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

Not Applicable

• Conditions: Myocardial Infarction; Myocardial Ischemia
• Interventions: Device: Cardiac Magnetic Resonance Imaging

• Registration Number: NCT02517255
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-06
• Primary Completion: 2017-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Magnetic Resonance Imaging	Cardiac Magnetic Resonance Imaging	Cardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Escola Paulista de Medicina - Universidade Federal de São Paulo; 🇧🇷 São Paulo, SP, Brazil