Skip to main content
Clinical Trials/NCT04220736
NCT04220736
Unknown
Not Applicable

EARLY Microvascular Dysfunction Prediction Using Quantitative Flow Ratio in ST-segment Elevation MYOcardial Infarction Patients With Pharmaco-Invasive Strategy (EARLY-MYO-QFR PI)

RenJi Hospital1 site in 1 country200 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ST Segment Elevation Myocardial Infarction
Sponsor
RenJi Hospital
Enrollment
200
Locations
1
Primary Endpoint
Cardiac magnetic resonance (CMR)
Last Updated
6 years ago

Overview

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 who underwent pharmaco-invasive strategy as the population. Contrast-enhanced CMR was performed 5 days after PCI as the reference standard.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
July 25, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 underwent successfully pharmaco-invasive strategy with half-dose alteplase.

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.

Outcomes

Primary Outcomes

Cardiac magnetic resonance (CMR)

Time Frame: Five days after PCI

Cardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing

Secondary Outcomes

  • TIMI Flow Grade (TFG)(One mins after PCI)
  • TIMI Myocardial Perfusion Grade (TMPG)(One mins after PCI)

Study Sites (1)

Loading locations...

Similar Trials