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Completed

NCT Number: NCT03780335

Early Prediction of QFR in STEMI-I

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computation of quantitative flow ratio

Diagnostic 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.

Primary outcomes

  1. Cardiac magnetic resonance (CMR)

    Time frame: Five days after PCI

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

Secondary outcomes

  1. TIMI Flow Grade (TFG)

    Time frame: One mins before PCI

    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.

  2. TIMI Flow Grade (TFG)

    Time frame: One mins after PCI

    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.

  3. TIMI Myocardial Perfusion Grade (TMPG)

    Time frame: One mins before PCI

    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.

  4. TIMI Myocardial Perfusion Grade (TMPG)

    Time frame: One mins after PCI

    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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: EARLYmyo-QFR-I

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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