NCT04220736 - Early Prediction of QFR in STEMI-Pharmaco-invasice | Crick

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

ST Segment Elevation Myocardial Infarction

Interventions

Computation of quantitative flow ratioDIAGNOSTIC_TEST

Computation of QFR was performed offline, using AngioPlus system(Pluse medical imaging technology, Shanghai, China). In the first step, 2 diagnostic angiographic projections before PCI, at least 25° apart, were selected and 3D reconstruction of the interrogated vessel without its side branches was performed. Then, the software computed the QFR.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Cardiac magnetic resonance (CMR)

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

Time frame: Five days after PCI

Secondary Outcomes

TIMI Flow Grade (TFG)

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.

Time frame: One mins before PCI

TIMI Flow Grade (TFG)

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.

Time frame: One mins after PCI

TIMI Myocardial Perfusion Grade (TMPG)

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.

Time frame: One mins before PCI

TIMI Myocardial Perfusion Grade (TMPG)

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.

Central Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477 pujun310@hotmail.com