Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease
Primary Purpose
ST Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCI
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis, Coronary physiological function, Quantitative fractional ratio, Percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Expected the patients who can not be followed up regularly according to the protocol or lost during the follow-up.
Sites / Locations
- Fuqing Hospital
- Fujian Medical University Union Hospital
- Fujian provincial hospital
- The First Hospital of Fuzhou City
- The First Hospital of Longyan City
- Ningde Hospital Affiliated to Ningde Normal University
- Putian Colloge affiliated Hospital
- The First Hospital of Putian City
- The Second Affiliated Hospital of Fujian Medical University
- QUANZHOU First Hospital
- Sanming First Hospital
- Hospital of Shaowu city
- The First Affiliated Hospital of Xiamen University
- Zhongshan Hospital Affiliated to Xiamen University
- Zhangzhou city's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
QFR-guided PCI group
CAG-guided PCI group
Arm Description
QFR-guided revascularization on non-culprit vessels in patients with STEMI
CAG-guided revascularization on non-culprit vessels in patients with STEMI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
2-year NACE
Incidence of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 24 months.
3-year NACE
Incidence of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at at 36 months.
MACE (Major Adverse Cardiovascular Events)
Incidence of composite events of cardiac death, recurrent myocardial infarction, or ischemia-driven revasculariztion at 12, 24, 36 months.
Full Information
NCT ID
NCT04259853
First Posted
February 5, 2020
Last Updated
July 29, 2022
Sponsor
Fujian Medical University
Collaborators
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04259853
Brief Title
Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease
Official Title
Quantitative Fractional Ratio-guided Non-culprit-vessel Revascularization in STEMI Patients With Multi-vessel Disease: a Prospective Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
Collaborators
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
41% -67% of patients with acute ST-segment elevation myocardial infarction (STEMI) have severe stenosis in non-culprit vessels (> 50% diameter stenosis). Compared with patients with single-vessel lesion, these patients with multi-vessel disease have a worse survival rate after percutaneous coronary intervention (PCI). Previous studies have shown that they not only receive more revascularization than the latter but also have a higher incidence of heart failure and more frequent electrical instability after myocardial infarction.
Early guidelines from European Society of Cardiology and the American College of Cardiology/American Heart Association discourage treating the non-culprit vessels in the acute phase. However, these recommendations are given mainly based on some small-sample retrospective studies.
With the use of second-generation drug-eluting stents and novel antithrombotic drugs, the clinical benefits from primary PCI and elective PCI have been greatly improved. Results from some small-sample prospective randomized studies have demonstrated that complete revascularization on STEMI patients with multi-vessel diseases is superior to a strategy of culprit-only revascularization. Especially, more recent two trials (PRAMI and CVLPRIT) further confirmed that complete revascularization in the acute phase can produce beneficial clinical results compared to culprit-only revascularization. However, stenting for these lesions in the two studies was decided based on angiographic findings regardless of whether the lesion caused myocardial ischemia or symptoms. Moreover, coronary angiography may underestimate and overestimate the functional severity of the lesion. Stent implantation preventively will lead to overtreatment, increasing additional cost and risk. Finally, not all such studies demonstrated positive findings. For example, the PRAGUE-13 study comparing angiography-guided complete revascularization with culprit-only treatment did not find that complete revascularization has more advantages. Therefore, the angiography-guided strategy for complete revascularization in STEMI patients with multi-vessel lesions remains questionable.
The clinical value of flow fractional reserve (FFR) as a gold standard for the assessment of coronary function in ischemia has been well confirmed in coronary intervention. Recently, three studies based on coronary functioning have shown that FFR-guided complete revascularization is superior to the strategy of only treating culprit lesion. However, clinical benefit of FFR is mainly from reducing the incidence of subsequent revascularization but not hard endpoints such as death. On the other hand, the time of treatment for non-culprit vessel was not completely consistent and not all patients in the FFR group received FFR measurements in these studies. Heterogeneities from these studies may weaken the clinical benefit of FFR in guiding complete revascularization in STEMI patients. Although the current guidelines recommend that non-culprit lesions be allowed for treatment when emergency PCI is performed on specific patients (Class IIa, Level A), it is still necessary to conduct studies targeted on these issues to further clarify the value of coronary functional approach in revascularization on non-culprit vessel of patients with STEMI. FFR also has certain limitations: first, FFR is an invasive test, which requires a pressure guide wire, in turn inevitably increases the cost of operation and may cause additional procedure-associated risks; secondly, drugs such as adenosine are required to maximize hyperemia of coronary artery, and these adverse drug reactions may increase the incidence of adverse clinical events, especially in the acute state of myocardial infarction.
Quantitative flow ratio (QFR) is a novel angiography-based method accurate assessing coronary physiological functions for deriving FFR without the use of pressure wire and induction of hyperemia. The three-dimensional reconstruction of the coronary arteries is performed through two angiographic images with an acquisition angle difference of > 25 °. The QFR value is finally calculated based on the flow velocity obtained by a method of frame rate counting. In the past five years, a vast number of studies confirmed QFR is highly consistent with FFR in the diagnosis of myocardial ischemia, and the diagnostic accuracy of QFR is significantly higher than that of quantitative coronary angiography. Recent studies have also shown that, compared with conventional angiography-guided PCI, QFR-guided PCI for patients with stable angina pectoris has significantly reduced adverse cardiovascular events such as death and revascularization. Especially, QFR and FFR can accurately assess the coronary physiological function status of non-culprit lesions in emergency PCI patients, and its effectiveness is consistent with FFR applied to patients with stable coronary heart disease. Although previous studies provided the theoretical support, there are still poor data on QFR-guided non-culprit revascularization on STEMI patients with multi-vessel disease. Thus, we hypothesized that strategies for QFR to assess all blood flow limiting lesions and guide revascularization during emergency PCI would lead to better short-term and long-term clinical outcomes for STEMI patients with multiple vessel lesions, including improved left ventricular function, less secondary revascularization, less frequency of hospitalization, lower medical costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1016 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QFR-guided PCI group
Arm Type
Experimental
Arm Description
QFR-guided revascularization on non-culprit vessels in patients with STEMI
Arm Title
CAG-guided PCI group
Arm Type
Active Comparator
Arm Description
CAG-guided revascularization on non-culprit vessels in patients with STEMI
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Revascularization on non culprit vessel
Primary Outcome Measure Information:
Title
NACE (Net Adverse Clinical Events)
Description
A composite endpoint of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
2-year NACE
Description
Incidence of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 24 months.
Time Frame
24 months
Title
3-year NACE
Description
Incidence of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at at 36 months.
Time Frame
36 months
Title
MACE (Major Adverse Cardiovascular Events)
Description
Incidence of composite events of cardiac death, recurrent myocardial infarction, or ischemia-driven revasculariztion at 12, 24, 36 months.
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
Stent thrombosis
Description
The incidence of stent thrombosis at 12, 24, 36 months.
Time Frame
up to 36 months
Title
Major bleeding
Description
The incidence of bleeding at 12, 24, 36 months.
Time Frame
up to 36 months
Title
Stroke
Description
The incidence of stroke at 12, 24, 36 months.
Time Frame
up to 36 months
Title
Cost-effective assessment
Description
Medical costs for procedure, hospitalization, and daily medicine.
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Expected the patients who can not be followed up regularly according to the protocol or lost during the follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lianglong Chen, MD, PhD
Organizational Affiliation
Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuqing Hospital
City
Fuqing
State/Province
Fujian
ZIP/Postal Code
350300
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian provincial hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The First Hospital of Fuzhou City
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350003
Country
China
Facility Name
The First Hospital of Longyan City
City
Longyan
State/Province
Fujian
ZIP/Postal Code
364000
Country
China
Facility Name
Ningde Hospital Affiliated to Ningde Normal University
City
Ningde
State/Province
Fujian
ZIP/Postal Code
352100
Country
China
Facility Name
Putian Colloge affiliated Hospital
City
Putian
State/Province
Fujian
ZIP/Postal Code
351100
Country
China
Facility Name
The First Hospital of Putian City
City
Putian
State/Province
Fujian
ZIP/Postal Code
351100
Country
China
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Facility Name
QUANZHOU First Hospital
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362002
Country
China
Facility Name
Sanming First Hospital
City
Sanming
State/Province
Fujian
ZIP/Postal Code
365000
Country
China
Facility Name
Hospital of Shaowu city
City
Shaowu
State/Province
Fujian
ZIP/Postal Code
354000
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Facility Name
Zhongshan Hospital Affiliated to Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Facility Name
Zhangzhou city's Hospital
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease
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