Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease

NCT04259853 | Enrolling By Invitation DMC

• 1 other identifier: the QFR-STEMI study
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 15

Brief Summary

About half of patients with ST-segment elevation myocardial infarction (STEMI) have multi-vessel lesions (\> 50% diameter stenosis). But how to deal with the non-culprit vessels is still controversial. Previous studies have shown that flow fractional reserve (FFR)-guided revascularization on non-culprit vessels can further improve prognosis of such patients. However, FFR requires the use of pressure guidewire and special drugs such as adenosine to maximize induction of hyperemia forcoronary artery, which will increase the cost of operation and may cause additional risks. Quantitative flow ratio (QFR) is a novel angiography-based method for deriving FFR without pressure wire or induction of hyperemia. In present, there still are poor data about QFR-guided revascularization on non-culprit vessels in patients with STEMI. The purpose of this study is to compare the clinical effects of QFR-guided with angiography-guided revascularization on non-culprit vessel in STEMI patients with multi-vessel lesions.

Conditions

ST Elevation Myocardial Infarction; Multi-Vessel Coronary Artery Stenosis

Keywords

ST Elevation Myocardial Infarction; Multi-Vessel Coronary Artery Stenosis; Coronary physiological function; Quantitative fractional ratio; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• NACE (Net Adverse Clinical Events)

  A composite endpoint of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 12 months.

  12 months

Secondary Outcomes (3)

• 2-year NACE

  24 months

• 3-year NACE

  36 months

• MACE (Major Adverse Cardiovascular Events)

  up to 36 months

Other Outcomes (4)

• Stent thrombosis

  up to 36 months

• Major bleeding

  up to 36 months

• Stroke

  up to 36 months

Study Arms (2)

QFR-guided PCI group

EXPERIMENTAL

QFR-guided revascularization on non-culprit vessels in patients with STEMI

Procedure: PCI

CAG-guided PCI group

ACTIVE COMPARATOR

CAG-guided revascularization on non-culprit vessels in patients with STEMI

Procedure: PCI

Interventions

PCI PROCEDURE

Revascularization on non culprit vessel

CAG-guided PCI group; QFR-guided PCI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable for emergency PCI within 12 hours;
• At least one lesion with a stenosis of 50% - 90% in the non culprit vessel and PCI required by the operator.
• Voluntary acceptance of all follow-up assessments required by the protocol.
• The subject (or legal guardian) who understands the protocol requirements and treatment procedures, and signs a written informed consent before performing the examination or operation specified in the scheme.

You may not qualify if:

• Left main lesion (a stenosis of ≥ 50%).
• STEMI caused by stent thrombosis.
• Non culprit vessels are chronic occlusive disease (CTO).
• The anatomy of non culprit vessels not suitable for PCI.
• The TIMI flow of non culprit vessels less than grade 2.
• Patients with one of the following conditions in the treatment of infarct related vessel:
• Coronary artery perforation.
• After the treatment, there is permanent no reflow (TIMI 0-1).
• The stent could not be implanted.
• Patients with Killip grade III-IV who can still not tolerate PCI again after treated for one week.
• Known severe cardiac valve dysfunction requiring surgery during follow-up.
• Subjects could not tolerate dual-antiplatelet therapy.
• Woman with pregnancy or planning to pregnancy.
• Patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
• Patients participating any other clinical trials.

Sponsors & Collaborators

• Fujian Medical University: lead
• Pulse Medical Imaging Technology (Shanghai) Co., Ltd: collaborator

Study Sites (15)

Fuqing Hospital

Fuqing, Fujian, 350300, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Fujian provincial hospital

Fuzhou, Fujian, 350001, China

Location

The First Hospital of Fuzhou City

Fuzhou, Fujian, 350003, China

Location

The First Hospital of Longyan City

Longyan, Fujian, 364000, China

Location

Ningde Hospital Affiliated to Ningde Normal University

Ningde, Fujian, 352100, China

Location

Putian Colloge affiliated Hospital

Putian, Fujian, 351100, China

Location

The First Hospital of Putian City

Putian, Fujian, 351100, China

Location

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

QUANZHOU First Hospital

Quanzhou, Fujian, 362002, China

Location

Sanming First Hospital

Sanming, Fujian, 365000, China

Location

Hospital of Shaowu city

Shaowu, Fujian, 354000, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

Location

Zhangzhou city's Hospital

Zhangzhou, Fujian, 363000, China

Location

Related Publications (20)

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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

Study Officials

• Lianglong Chen, MD, PhD

  Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: January 30, 2020
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2026
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)