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Early Prediction of QFR in STEMI-Pharmaco-invasice (EARLYmyoQFR-PI)

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

ST Segment Elevation Myocardial Infarction

Treatments

Diagnostic Test: Computation of quantitative flow ratio

Study type

Observational

Funder types

Other

Identifiers

NCT04220736
16CR3034C

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

MVO group
Description:
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.
Treatment:
Diagnostic Test: Computation of quantitative flow ratio
Non-MVO group
Description:
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.
Treatment:
Diagnostic Test: Computation of quantitative flow ratio

Trial contacts and locations

1

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Central trial contact

Jun Pu, MD,PhD

Data sourced from clinicaltrials.gov

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