ST Elevation Myocardial InfarctionNCT04259853
Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease
A study testing PCI in people with ST Elevation Myocardial Infarction and Multi-Vessel Coronary Artery Stenosis, run by Fujian Medical University at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- 15 sitesChina
- Study dates
- 30 Jan 2020to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Fuqing Hospital
Fuqing, Fujian, 350300
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian provincial hospital
Fuzhou, Fujian, 350001
The First Hospital of Fuzhou City
Fuzhou, Fujian, 350003
The First Hospital of Longyan City
Longyan, Fujian, 364000
Ningde Hospital Affiliated to Ningde Normal University
Ningde, Fujian, 352100
Putian Colloge affiliated Hospital
Putian, Fujian, 351100
The First Hospital of Putian City
Putian, Fujian, 351100
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
QUANZHOU First Hospital
Quanzhou, Fujian, 362002
Sanming First Hospital
Sanming, Fujian, 365000
Hospital of Shaowu city
Shaowu, Fujian, 354000
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
Zhangzhou city's Hospital
Zhangzhou, Fujian, 363000
About this study
Official title: Quantitative Fractional Ratio-guided Non-culprit-vessel Revascularization in STEMI Patients With Multi-vessel Disease: a Prospective Multi-center Randomized Controlled Trial
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.
Read the 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.
- Being tested
- PCI
- Keywords
- ST Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis, Coronary physiological function, Quantitative fractional ratio, Percutaneous coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Revascularization on non culprit vessel
| Study group | Role | What they receive |
|---|---|---|
| QFR-guided PCI group | Experimental | QFR-guided revascularization on non-culprit vessels in patients with STEMI Receives: Procedure: PCI |
| CAG-guided PCI group | Active comparator | CAG-guided revascularization on non-culprit vessels in patients with STEMI Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
2-year NACE
Incidence of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 24 months.
Measured: 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.
Measured: 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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start30 Jan 2020
- Primary completion30 Jan 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,016 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
- Responsible party
- Principal investigator, Lianglong Chen, Fujian Medical University
- Investigators
- Lianglong Chen, MD, PhD, Principal investigator, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259853
- Sponsor's protocol ID
- the QFR-STEMI study
- Status last verified
- Jul 2022
- First submitted
- 5 Feb 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corpus RA, House JA, Marso SP, Grantham JA, Huber KC Jr, Laster SB, Johnson WL, Daniels WC, Barth CW, Giorgi LV, Rutherford BD. Multivessel percutaneous coronary intervention in patients with multivessel disease and acute myocardial infarction. Am Heart J. 2004 Sep;148(3):493-500. doi: 10.1016/j.ahj.2004.03.051.
PubMed 15389238Hanratty CG, Koyama Y, Rasmussen HH, Nelson GI, Hansen PS, Ward MR. Exaggeration of nonculprit stenosis severity during acute myocardial infarction: implications for immediate multivessel revascularization. J Am Coll Cardiol. 2002 Sep 4;40(5):911-6. doi: 10.1016/s0735-1097(02)02049-1.
PubMed 12225715Janardhanan R, Kenchaiah S, Velazquez EJ, Park Y, McMurray JJ, Weaver WD, Finn PV, White HD, Marin-Neto JA, O'Connor C, Pfeffer MA, Califf RM, Solomon SD; VALIANT Investigators. Extent of coronary artery disease as a predictor of outcomes in acute myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. Am Heart J. 2006 Jul;152(1):183-9. doi: 10.1016/j.ahj.2005.11.013.
PubMed 16824854Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011 Dec 6;124(23):e574-651. doi: 10.1161/CIR.0b013e31823ba622. Epub 2011 Nov 7. No abstract available.
PubMed 22064601Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
PubMed 20060578Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
PubMed 20445180Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
PubMed 19249633Khattab AA, Abdel-Wahab M, Rother C, Liska B, Toelg R, Kassner G, Geist V, Richardt G. Multi-vessel stenting during primary percutaneous coronary intervention for acute myocardial infarction. A single-center experience. Clin Res Cardiol. 2008 Jan;97(1):32-8. doi: 10.1007/s00392-007-0570-4. Epub 2007 Aug 17.
PubMed 17694377Hassan A, ElGuindy A, Antoniucci D. Culprit lesion-only versus complete revascularization in patients with STEMI: Lessons learned from PRAMI, CvLPRIT, and DANAMI-3 PRIMULTI. Glob Cardiol Sci Pract. 2015 Dec 22;2015(5):60. doi: 10.5339/gcsp.2015.60. eCollection 2015. No abstract available.
PubMed 26925405Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013 Sep 19;369(12):1115-23. doi: 10.1056/NEJMoa1305520. Epub 2013 Sep 1.
PubMed 23991625Kelly DJ, McCann GP, Blackman D, Curzen NP, Dalby M, Greenwood JP, Fairbrother K, Shipley L, Kelion A, Heatherington S, Khan JN, Nazir S, Alahmar A, Flather M, Swanton H, Schofield P, Gunning M, Hall R, Gershlick AH. Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design. EuroIntervention. 2013 Feb 22;8(10):1190-8. doi: 10.4244/EIJV8I10A183.
PubMed 23425543Hlinomaz O, Groch L, Poloková K, et al. Multivessel coronary disease diagnosed at the time of primary PCI for STEMI: complete revascularization versus conservative strategy. PRAGUE-13 trial. Kardiol Rev Int Med 2015;17:214-220.
Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
PubMed 26347918Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
PubMed 28317428Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
PubMed 31475795
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Fractional Ratio-guided Non-culprit-vessel Revascularization in STEMI Patients With Multi-vessel Disease: a Prospective Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04259853
- Acronym / sponsor ID
- the QFR-STEMI study
- Keywords
- ST Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis, Coronary physiological function, Quantitative fractional ratio, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,016 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QFR-guided PCI group | Experimental | Procedure: PCIQFR-guided revascularization on non-culprit vessels in patients with STEMI |
| CAG-guided PCI group | Active comparator | Procedure: PCICAG-guided revascularization on non-culprit vessels in patients with STEMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIRevascularization on non culprit vessel | Procedure or surgery | CAG-guided PCI group, QFR-guided PCI group |
Primary outcome
NACE (Net Adverse Clinical Events)
Time frame: 12 months
A composite endpoint of all-cause mortality, recurrent myocardial infarction, any revascularization, hospitalization for heart failure, stroke, or major bleeding at 12 months.
3 secondary outcomes
2-year NACE
Time frame: 24 months
3-year NACE
Time frame: 36 months
MACE (Major Adverse Cardiovascular Events)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 15389238Corpus RA, House JA, Marso SP, Grantham JA, Huber KC Jr, Laster SB, Johnson WL, Daniels WC, Barth CW, Giorgi LV, Rutherford BD. Multivessel percutaneous coronary intervention in patients with multivessel disease and acute myocardial infarction. Am Heart J. 2004 Sep;148(3):493-500. doi: 10.1016/j.ahj.2004.03.051.
- Background: PubMed 12225715Hanratty CG, Koyama Y, Rasmussen HH, Nelson GI, Hansen PS, Ward MR. Exaggeration of nonculprit stenosis severity during acute myocardial infarction: implications for immediate multivessel revascularization. J Am Coll Cardiol. 2002 Sep 4;40(5):911-6. doi: 10.1016/s0735-1097(02)02049-1.
- Background: PubMed 16824854Janardhanan R, Kenchaiah S, Velazquez EJ, Park Y, McMurray JJ, Weaver WD, Finn PV, White HD, Marin-Neto JA, O'Connor C, Pfeffer MA, Califf RM, Solomon SD; VALIANT Investigators. Extent of coronary artery disease as a predictor of outcomes in acute myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. Am Heart J. 2006 Jul;152(1):183-9. doi: 10.1016/j.ahj.2005.11.013.
- Background: PubMed 22064601Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011 Dec 6;124(23):e574-651. doi: 10.1161/CIR.0b013e31823ba622. Epub 2011 Nov 7. No abstract available.
- Background: PubMed 20060578Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
- Background: PubMed 20445180Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
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- BackgroundHlinomaz O, Groch L, Poloková K, et al. Multivessel coronary disease diagnosed at the time of primary PCI for STEMI: complete revascularization versus conservative strategy. PRAGUE-13 trial. Kardiol Rev Int Med 2015;17:214-220.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lianglong Chen, MD, PhD principal investigator
Fujian Medical University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with ST Elevation Myocardial Infarction and Multi-Vessel Coronary Artery Stenosis, run by Fujian Medical University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE (Net Adverse Clinical Events) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259853, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.