Early Prediction of QFR in STEMI-I

Completed

• Conditions: ST Segment Elevation Myocardial Infarction
• Interventions: Diagnostic Test: Computation of quantitative flow ratio

• Registration Number: NCT03780335
• Lead Sponsor: RenJi Hospital

Brief Summary

The study intends to provide important data on whether the noval method using quantitative flow ratio could predict microvascular dysfunction.

Detailed Description

Microvascular dysfunction (MVD) is a serious complication of PCI, which happens frequently after STEMI and always correlates with a poor prognosis. However, precise and simplified assessment of MVD is difficult, especially in the acute phase of STEMI patients. Resent studies suggested that FFR could be overestimated when MVD exists. But whether the overestimated value of FFR caused by CMR defined MVO could reflect microcirculation function is still unclear.

This study is a retrospective study using STEMI patients with TFG 2/3 of the infarct vessel on initial angiography and presumed culprit lesion ≥50% as the population. Contrast-enhanced CMR was performed 5 days after PCI as the reference standard.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2018-08
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-30
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• STEMI patients treated with revasculation within 12 hours from onset of symptoms to PCI time and received CMR 5 days afterwards. STEMI was defined as a combination of the following: chest pain for more than 30min, electrocardiographic (ECG) changing with ST segment elevation of >2 mm in at least 2 precordial leads and >1 mm in limb leads, and abnormal troponin levels or CKMB levels higher than twice the upper limit of normal.
• Patients with TFG 2/3 in the initial angiography of the culprit vessel.

Exclusion Criteria

• Patients with left bundle branch block in the presenting ECG, cardiogenic shock, PCI or bypass surgery history.
• Patients with residual stenosis <50%.
• Patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MVO group	Computation of quantitative flow ratio	CMR was performed in all the cases. According to the results of CMR, we divided the study population into MVO group and Non-MVO group.
Non-MVO group	Computation of quantitative flow ratio	CMR was performed in all the cases. According to the results of CMR, we divided the study population into MVO group and Non-MVO group.

Primary Outcome Measures

Name	Time	Method
Cardiac magnetic resonance (CMR)	Five days after PCI	Cardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing

Secondary Outcome Measures

Name	Time	Method
TIMI Flow Grade (TFG)	One mins after PCI	TIMI Flow Grade (TFG) assesses flow in the epicardial arteries. Type zero perfusion expressed not antegrade movement away the occlusion; type two is a minimum, inadequate perfusion of contrast average round the mass; type three (partial perfusion) is a perfect just limited perfusion from the distal coronary bed by contrast element; and type three (complete perfusion) is an antegrade movement to the whole distal artery at a regular flow.
TIMI Myocardial Perfusion Grade (TMPG)	One mins after PCI	TIMI Myocardial Perfusion Grade (TMPG) assesses flow in the micrevessels. TMPG0: no or minimal blush; TMPG1: Stain present Blush persists on next injection; TMPG2: Dye strongly persistent at end of washout Gone by next injection; TMPG3: normal ground glass appearance of blush Dye mildly persistentat end of washout.