Clinical trial NCT03910400: Early Assessment of QFR in STEMI-II
Official title: EARLY Microvascular Dysfunction Assessment Using Quantitative Flow Ratio After ST-segment Elevation MYOcardial Infarction (EARLY-MYO-QFR II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Keywords: STEMI
Cardiac magnetic resonance
balloon catheter
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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.

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.
* 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.

Primary outcomes:
measure: Cardiac magnetic resonance (CMR)
timeFrame: Five days after PCI
Secondary outcomes:
measure: TIMI Flow Grade (TFG)
timeFrame: One minutes after PCI
measure: TIMI Myocardial Perfusion Grade (TMPG)
timeFrame: One minutes after PCI
measure: ST-segment resolution (STR)
timeFrame: 90 minutes after PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Study officials:
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