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

April 8, 2020 updated by: RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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

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.
EXPERIMENTAL: 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac magnetic resonance (CMR)
Time Frame: Five days after PCI
Cardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing
Five days after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI Flow Grade (TFG)
Time Frame: One minutes 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.
One minutes after PCI
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame: One minutes after PCI
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.
One minutes after PCI
ST-segment resolution (STR)
Time Frame: 90 minutes after PCI
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.
90 minutes after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (ACTUAL)

April 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16CR3034B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST Segment Elevation Myocardial Infarction

Clinical Trials on Computation of quantitative flow ratio

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe