- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586582
ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction
The First Affiliated Hospital of Chongqing Medical University.
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%).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Single-branch coronary artery stenosis or occlusion
- Restoration of coronary perfusion to TIMI flow grade 3 after PCI
Exclusion Criteria:
- A prior history of the acute coronary syndrome
- Coronary revascularization
- Severe chronic kidney disease
- Intracardiac pacing leads or other implants precluding CMR-LGE
- Hemodynamic instability
- Known claustrophobia
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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%
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ST-segment resolution<40.15%
Time Frame: 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.
|
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.
|
ST-segment resolution>40.15%
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dongying Zhang, phD., First Affiliated Hospital of Chongqing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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