Early Assessment of QFR in STEMI-II

NCT03910400 | Unknown DMC

• 1 other identifier: 16CR3034B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study EARLY-MYO-QFR-I.

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI; Cardiac magnetic resonance; balloon catheter

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 (3)

• TIMI Flow Grade (TFG)

  One minutes after PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  One minutes after PCI

• ST-segment resolution (STR)

  90 minutes after PCI

Study Arms (2)

MVO group

EXPERIMENTAL

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

EXPERIMENTAL

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

After stents were implanted whenever technically possible in the STEMI patients, the investigators created a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia. Computation of QFR was performed offline, using AngioPlus system(Pluse medical imaging technology, Shanghai, China). In the first step, 2 diagnostic angiographic projections with the artifical stenosis, 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+)

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.
• Stents were implanted whenever technically possible.
• TFG 2/3 after PCI.

You may not qualify if:

• Patients with left bundle branch block in the presenting ECG, cardiogenic shock, previous PCI or bypass surgery, previous AMI history.
• Patients with trouble in partially inflating a balloon catheter during pharmacologic hyperemia.
• 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 Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

Related Publications (13)

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• Spitaleri G, Tebaldi M, Biscaglia S, Westra J, Brugaletta S, Erriquez A, Passarini G, Brieda A, Leone AM, Picchi A, Ielasi A, Girolamo DD, Trani C, Ferrari R, Reiber JHC, Valgimigli M, Sabate M, Campo G. Quantitative Flow Ratio Identifies Nonculprit Coronary Lesions Requiring Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease. Circ Cardiovasc Interv. 2018 Feb;11(2):e006023. doi: 10.1161/CIRCINTERVENTIONS.117.006023.

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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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 10, 2020

Record last verified: 2019-06

Locations

CN (1)