Early Prediction of QFR in STEMI-Pharmaco-invasice

NCT ID: NCT04220736

Last Updated: 2020-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-07-25

Brief Summary

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

Detailed Description

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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.

Conditions

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ST Segment Elevation Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MVO group

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.

Computation of quantitative flow ratio

Intervention Type 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.

Non-MVO group

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.

Computation of quantitative flow ratio

Intervention Type 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.

Interventions

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Computation of quantitative flow ratio

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Pu, MD,PhD

Role: CONTACT

86-21-68383477

Facility Contacts

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Jun Pu, Professor

Role: primary

86-21-68383477

References

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Sheng X, Ding S, Ge H, Sun Y, Kong L, He J, Pu J, He B. Intracoronary infusion of alprostadil and nitroglycerin with targeted perfusion microcatheter in STEMI patients with coronary slow flow phenomenon. Int J Cardiol. 2018 Aug 15;265:6-11. doi: 10.1016/j.ijcard.2018.04.119. Epub 2018 Apr 25.

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Other Identifiers

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16CR3034C

Identifier Type: -

Identifier Source: org_study_id

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