Early Prediction of QFR in STEMI-Pharmaco-invasice

NCT04220736 | Unknown DMC

• 1 other identifier: 16CR3034C
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI; Cardiac magnetic resonance; pharmaco-invasive

Outcome Measures

Primary Outcomes (1)

• Cardiac magnetic resonance (CMR)

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

  Five days after PCI

Secondary Outcomes (4)

• TIMI Flow Grade (TFG)

  One mins before PCI

• TIMI Flow Grade (TFG)

  One mins after PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  One mins before PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  One mins after PCI

Study Arms (2)

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.

Diagnostic Test: Computation of quantitative flow ratio

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.

Diagnostic Test: Computation of quantitative flow ratio

Interventions

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.

MVO group; Non-MVO group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

STEMI patients who underwent successful pharmaco-invasive strategy and presumed culprit lesion ≥50%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (13)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: January 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 25, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-01

Locations

CN (1)