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Early Assessment of QFR in STEMI-II

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03910400
Acronym
EARLYmyoQFR-II
Enrollment
200
Registered
2019-04-10
Start date
2019-02-01
Completion date
2021-03-01
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMI, Cardiac magnetic resonance, balloon catheter

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.

Interventions

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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac magnetic resonance (CMR)Five days after PCICardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing

Secondary

MeasureTime frameDescription
TIMI Flow Grade (TFG)One minutes after PCITIMI 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)One minutes after PCITIMI 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)90 minutes after PCIThe 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.

Countries

China

Contacts

Primary ContactJun Pu, MD,PhD
pujun310@hotmail.com86-21-68383477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026