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Early Assessment of QFR in STEMI-II (EARLYmyoQFR-II)

Primary Purpose

ST Segment Elevation Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Computation of quantitative flow ratio

About this trial

This is an interventional diagnostic trial for ST Segment Elevation Myocardial Infarction focused on measuring STEMI, Cardiac magnetic resonance, balloon catheter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

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.

Sites / Locations

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MVO group

Non-MVO group

Arm Description

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.

Outcomes

Primary Outcome Measures

Cardiac magnetic resonance (CMR)

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

Secondary Outcome Measures

TIMI Flow Grade (TFG)

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.

TIMI Myocardial Perfusion Grade (TMPG)

TIMI Myocardial Perfusion Grade (TMPG) assesses flow in the microvessels. 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 persistent at end of washout.

ST-segment resolution (STR)

The ST-segment resolution (STR) was measured after the end of the QRS complex J point in leads I, aVL, and V1 to V6 for anterior MI, and leads II, III, aVF, V5, and V6 for nonanterior MI.

Full Information

NCT ID

NCT03910400

First Posted

April 9, 2019

Last Updated

April 8, 2020

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03910400

Brief Title

Early Assessment of QFR in STEMI-II

Acronym

EARLYmyoQFR-II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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 microvascular obstruction (MVO) could reflect microvascular function is still unclear. In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis. This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Segment Elevation Myocardial Infarction

Keywords

STEMI, Cardiac magnetic resonance, balloon catheter

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MVO group

Arm Type

Experimental

Arm Description

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.

Arm Title

Non-MVO group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Computation of quantitative flow ratio

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cardiac magnetic resonance (CMR)

Description

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

Time Frame

Five days after PCI

Secondary Outcome Measure Information:

Title

TIMI Flow Grade (TFG)

Description

Time Frame

One minutes after PCI

Title

TIMI Myocardial Perfusion Grade (TMPG)

Description

Time Frame

One minutes after PCI

Title

ST-segment resolution (STR)

Description

The ST-segment resolution (STR) was measured after the end of the QRS complex J point in leads I, aVL, and V1 to V6 for anterior MI, and leads II, III, aVF, V5, and V6 for nonanterior MI.

Time Frame

90 minutes after PCI

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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. Stents were implanted whenever technically possible. TFG 2/3 after PCI. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Pu, MD,PhD

Phone

86-21-68383477

pujun310@hotmail.com

Facility Information:

Facility Name

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

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Pu

Phone

86-21-68383477

pujun310@hotmail.com

12. IPD Sharing Statement

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Early Assessment of QFR in STEMI-II

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