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

NCT ID: NCT02517255

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-04-30

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.

Conditions

Myocardial Infarction; Myocardial Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiac Magnetic Resonance Imaging

Cardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months.

Group Type: EXPERIMENTAL

Cardiac Magnetic Resonance Imaging

Intervention Type: DEVICE

7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images

Interventions

Cardiac Magnetic Resonance Imaging

7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luiz Fernando Ybarra

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio C Carvalho, MD, PhD

Role: STUDY_CHAIR

Full Professor at Universidade Federal de São Paulo

Locations

Escola Paulista de Medicina - Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

518.844

Identifier Type: -

Identifier Source: org_study_id