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ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction

Sponsor
Chongqing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04586582
Collaborator
(none)
42
Enrollment
1
Location
21.9
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . In clinical work, in patients have poor ST-segment decline, the investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of myocardial scar.

The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to provide convenient, cheap and widely used test method for patients who cannot tolerate CMR-LGE.

42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured on the baseline and 24 hours after PCI. The study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (LGE- CMR), with transmural myocardial scar (>75%) or non-transmural myocardial scar (<75%).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ST-segment resolution <40.15%

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
42 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The First Affiliated Hospital of Chongqing Medical University.
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
ST-segment resolution <40.15%

ST-segment resolution <40.15%

Diagnostic Test: ST-segment resolution <40.15%
Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars.
ST-segment resolution >40.15%

ST-segment resolution >40.15%

Diagnostic Test: ST-segment resolution <40.15%
Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars.

Outcome Measures

Primary Outcome Measures

  1. ST-segment resolution<40.15% [1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.]

    CMR-LGE was performed to evaluate myocardial scars.

  2. ST-segment resolution>40.15% [1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.]

    CMR-LGE was performed to evaluate myocardial scars.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Single-branch coronary artery stenosis or occlusion

  2. Restoration of coronary perfusion to TIMI flow grade 3 after PCI

Exclusion Criteria:

  1. A prior history of the acute coronary syndrome

  2. Coronary revascularization

  3. Severe chronic kidney disease

  4. Intracardiac pacing leads or other implants precluding CMR-LGE

  5. Hemodynamic instability

  6. Known claustrophobia

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of Chongqing medical university Chongqing Chongqing China 400016

Sponsors and Collaborators

  • Chongqing Medical University

Investigators

  • Study Director: Dongying Zhang, phD., First Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dongying Zhang, Clinical Professor, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT04586582
Other Study ID Numbers:
  • 20180701
First Posted:
Oct 14, 2020
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Oct 14, 2020