Early Assessment of QFR in STEMI-II (EARLYmyoQFR-II)

Shanghai Jiao Tong University

Status: Unknown

Conditions: ST Segment Elevation Myocardial Infarction

Treatments: Diagnostic Test: Computation of quantitative flow ratio

Study type: Interventional

Funder types: Other

Identifiers

NCT03910400

16CR3034B

Details and patient eligibility

About

The study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study EARLY-MYO-QFR-I.

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 microvascular obstruction (MVO) could reflect microvascular function is still unclear.

In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis.

This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.

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.
• Stents were implanted whenever technically possible.
• TFG 2/3 after PCI.

Exclusion criteria

• Patients with left bundle branch block in the presenting ECG, cardiogenic shock, previous PCI or bypass surgery, previous AMI history.
• Patients with trouble in partially inflating a balloon catheter during pharmacologic hyperemia.
• Patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

MVO group

Experimental 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

Experimental 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