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Early Prediction of QFR in STEMI-I

EARLY Microvascular Dysfunction Prediction Using Quantitative Flow Ratio After ST-segment Elevation MYOcardial Infarction (EARLY-MYO-QFR I)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03780335
Acronym
EARLYmyo-QFR-I
Enrollment
162
Registered
2018-12-19
Start date
2015-01-01
Completion date
2018-09-30
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI, Cardiac magnetic resonance

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 with TFG 2/3 of the infarct vessel on initial angiography and presumed culprit lesion ≥50% as the population. Contrast-enhanced CMR was performed 5 days after PCI as the reference standard.

Interventions

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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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 with TFG 2/3 in the initial angiography of the culprit vessel.

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac magnetic resonance (CMR)Five days after PCICardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing

Secondary

MeasureTime frameDescription
TIMI Flow Grade (TFG)One mins before PCITIMI 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.
TIMI Myocardial Perfusion Grade (TMPG)One mins before PCITIMI 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026