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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04586582
Other study ID # 20180701
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date April 30, 2019

Study information

Verified date October 2020
Source Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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%).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 30, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China The first affiliated hospital of Chongqing medical university Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ST-segment resolution<40.15% 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.
Primary ST-segment resolution>40.15% 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.
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