NCT02517255

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

July 27, 2015

Last Update Submit

February 12, 2019

Conditions

Myocardial InfarctionMyocardial Ischemia

Keywords

ST segment elevation myocardial infarctionFailed ThrombolysisRescue Percutaneous Coronary InterventionCardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Cardiac Magnetic Resonance Imaging

EXPERIMENTAL

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

Interventions

Cardiac Magnetic Resonance ImagingDEVICE

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

Cardiac Magnetic Resonance Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Paulista de Medicina - Universidade Federal de São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Myocardial InfarctionMyocardial IschemiaST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Antonio C Carvalho, MD, PhD

    Full Professor at Universidade Federal de São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 6, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

April 1, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

BR(1)