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

NCT04586582 | Completed

• 1 other identifier: 20180701
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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%).

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

ST-segment resolution <40.15%

ST-segment resolution \<40.15%

Diagnostic Test: ST-segment resolution <40.15%

ST-segment resolution >40.15%

ST-segment resolution \>40.15%

Diagnostic Test: ST-segment resolution <40.15%

Interventions

ST-segment resolution <40.15% DIAGNOSTIC_TEST

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%

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

42 patients.

You may qualify if:

• Single-branch coronary artery stenosis or occlusion
• Restoration of coronary perfusion to TIMI flow grade 3 after PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The first affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Dongying Zhang, phD.

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: July 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: April 30, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CN (1)