Acute ST Segment Elevation Myocardial InfarctionFLOWER-MINCT02943954
FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
A study testing Angiography guided PCI and Fractional Flow Reserve (FFR) in people with Acute ST Segment Elevation Myocardial Infarction and Acute Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
- What is being tested?
- Angiography guided PCI and Fractional Flow Reserve (FFR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Jan 2022
- 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
- STEMI patients ≥ 18 years old with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% stenosis judged amenable to PCI in at least one additional non-culprit lesion
- Written informed consent
Who cannot join
- Patients with cardiogenic shock (SBP < 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
- Patients with MVD referred to surgery for CABG or treatment of acute complications (e.g. ventricular septal rupture)
- Patients with one-vessel disease
- Previous coronary bypass surgery
- Extremely tortuous, calcified coronary vessels or chronic total occlusion (CTO)
- Life expectancy < 2 years
Show all 9Show fewer
- Patients with known hypersensitivity to adenosine
- Pregnancy
- Participation in another interventional therapeutic study at the same time or within 3 months prior to the beginning of the present study
Trial locations and contacts
1 site in 1 country.
About this study
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).
The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.
The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.
Read the detailed description
The optimal revascularisation strategy in STEMI patients with MVD is currently debated. Recent data suggest that MV-PCI may be the most appropriate option for treating such patients. Consequently, the real challenge becomes to define what MVD is, in the context of acute MI, in order to limit revascularisation by PCI to vessels that truly need it. Visual estimation of the degree of coronary stenoses is a poor indicator of their haemodynamic severity. FFR is precisely designed and recommended in current guidelines to provide objective guidance for the functional assessment of lesion severity during coronary angiography in stable patients, but it has not been validated in STEMI patients with MVD. The purpose of the present trial will therefore be to investigate the relevance of FFR to guide the revascularisation management of patients at the acute stage of STEMI.
STEMI patients with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% diameter stenosis by visual estimate, in which revascularization is contemplated and judged amenable to PCI in at least one additional non-culprit lesion will be randomized into two groups: angiography-guided PCI or FFR-guided PCI.
If the patient is randomized to the angiography-guided PCI, all the lesions indicated beforehand will be treated. If the patient is randomized to the FFR-guided PCI, measurements of FFR of non-infarct related lesion(s) will be performed and only those lesions with a FFR ≤ 0.80 will be treated.
The use of drug-eluting stents is encouraged in both strategies. All patients will receive optimal medical therapy (including dual antiplatelet therapy, beta-blockers, statins, ACE-I or ARB) as recommended in international guidelines in both strategies.
Clinical follow-up will be performed at discharge, 30-day, 6 month and one-year. Rates of major adverse cardiac events, functional class and number of anti-anginal medications used will be collected. If the patient has been rehospitalized since index hospital discharge, the discharge summary and all relevant information will be collected.
- Conditions
- Acute ST Segment Elevation Myocardial Infarction, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
- Being tested
- Angiography guided PCI, Fractional Flow Reserve (FFR)
- Keywords
- Fractional Flow Reserve
- 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.
Angiography guided PCIProcedure or surgery
Fractional Flow Reserve (FFR)Device
| Study group | Role | What they receive |
|---|---|---|
| Angiography guided PCI | Other | Revascularisation of non-culprit lesions guided by PCI Receives: Procedure: Angiography guided PCI |
| FFR guided PCI | Other | Revascularisation of non-culprit lesions guided by FFR measurement Receives: Device: Fractional Flow Reserve (FFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major adverse cardiac events
Number of deaths, myocardial infarctions and unplanned hospitalization leading to urgent revascularizations at one year.
Measured: 1 year
Secondary outcomes (12)
Deaths
Measured: 1 year
Myocardial infarctions
Measured: 1 year
Repeat revascularizations
Measured: 1 year
Rate of nonculprit artery target lesion treated by urgent revascularization
Measured: 1 year
Rates of major adverse cardiac events at 30 days and 6 months
Measured: 30 days and 6 months
Rehospitalization for angina during the follow up period
Measured: 1 year
Procedure time
Measured: 5 days
Functional class at 1 year
The functional class is assessed with the use of the Canadian Cardiovascular Society classification of angina.
Measured: 1 year
Health-related quality of life
Health-related quality of life is assessed by the European Quality of Life-5 Dimensions [EQ-5D] questionnaires
Measured: 1 year
Anti-anginal medications used
Number of anti-anginal medications used
Measured: 1 month, 6 months and 1 year
Cost effectiveness
Incremental cost effectiveness ratio (ICER) using the composite endpoint (all-cause death, myocardial infarctions and repeat revascularizations).
Measured: 1 year
Cost utility
Incremental cost-utility ration (ICUR) using quality-adjusted life years (QALYs)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion24 Oct 2020
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Etienne PUYMIRAT, MD, Principal investigator, AP - HP, Hôpital Europeen Georges-Pompidou, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943954
- Sponsor's protocol ID
- P150943
- Other IDs
- 2016-A00418-43, AOM15608
- Acronym
- FLOWER-MI
- Status last verified
- Nov 2021
- First submitted
- 7 Sep 2016
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PubMed 25173339Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PubMed 19144937Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.
PubMed 21232721Engstrom 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 26347918Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, Ngaleu Siaha F, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, Djadi-Prat J, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction. Circ Cardiovasc Interv. 2024 Jun;17(6):e013913. doi: 10.1161/CIRCINTERVENTIONS.123.013913. Epub 2024 May 24.
PubMed 38785084Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.
PubMed 34420366Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
PubMed 33999545Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.
PubMed 32000067
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02943954
- Acronym / sponsor ID
- FLOWER-MI / P150943
- Conditions
- Acute ST Segment Elevation Myocardial Infarction, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
- Keywords
- Fractional Flow Reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,170 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Abbott, Ministry of Health, France
- Study start
- Dec 2016 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- 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.
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).
The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.
The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.
Detailed description
The optimal revascularisation strategy in STEMI patients with MVD is currently debated. Recent data suggest that MV-PCI may be the most appropriate option for treating such patients. Consequently, the real challenge becomes to define what MVD is, in the context of acute MI, in order to limit revascularisation by PCI to vessels that truly need it. Visual estimation of the degree of coronary stenoses is a poor indicator of their haemodynamic severity. FFR is precisely designed and recommended in current guidelines to provide objective guidance for the functional assessment of lesion severity during coronary angiography in stable patients, but it has not been validated in STEMI patients with MVD. The purpose of the present trial will therefore be to investigate the relevance of FFR to guide the revascularisation management of patients at the acute stage of STEMI.
STEMI patients with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% diameter stenosis by visual estimate, in which revascularization is contemplated and judged amenable to PCI in at least one additional non-culprit lesion will be randomized into two groups: angiography-guided PCI or FFR-guided PCI.
If the patient is randomized to the angiography-guided PCI, all the lesions indicated beforehand will be treated. If the patient is randomized to the FFR-guided PCI, measurements of FFR of non-infarct related lesion(s) will be performed and only those lesions with a FFR ≤ 0.80 will be treated.
The use of drug-eluting stents is encouraged in both strategies. All patients will receive optimal medical therapy (including dual antiplatelet therapy, beta-blockers, statins, ACE-I or ARB) as recommended in international guidelines in both strategies.
Clinical follow-up will be performed at discharge, 30-day, 6 month and one-year. Rates of major adverse cardiac events, functional class and number of anti-anginal medications used will be collected. If the patient has been rehospitalized since index hospital discharge, the discharge summary and all relevant information will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography guided PCI | Other | Procedure: Angiography guided PCIRevascularisation of non-culprit lesions guided by PCI |
| FFR guided PCI | Other | Device: Fractional Flow Reserve (FFR)Revascularisation of non-culprit lesions guided by FFR measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- STEMI patients ≥ 18 years old with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% stenosis judged amenable to PCI in at least one additional non-culprit lesion
- Written informed consent
Key exclusion criteria (9 listed)
- Patients with cardiogenic shock (SBP < 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
- Patients with MVD referred to surgery for CABG or treatment of acute complications (e.g. ventricular septal rupture)
- Patients with one-vessel disease
- Previous coronary bypass surgery
- Extremely tortuous, calcified coronary vessels or chronic total occlusion (CTO)
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 |
|---|---|---|
| Angiography guided PCI | Procedure or surgery | Angiography guided PCI |
| Fractional Flow Reserve (FFR) | Device | FFR guided PCI |
Primary outcome
Rate of major adverse cardiac events
Time frame: 1 year
Number of deaths, myocardial infarctions and unplanned hospitalization leading to urgent revascularizations at one year.
12 secondary outcomes
Deaths
Time frame: 1 year
Myocardial infarctions
Time frame: 1 year
Repeat revascularizations
Time frame: 1 year
Rate of nonculprit artery target lesion treated by urgent revascularization
Time frame: 1 year
Rates of major adverse cardiac events at 30 days and 6 months
Time frame: 30 days and 6 months
Rehospitalization for angina during the follow up period
Time frame: 1 year
Procedure time
Time frame: 5 days
Functional class at 1 year
Time frame: 1 year
Health-related quality of life
Time frame: 1 year
Anti-anginal medications used
Time frame: 1 month, 6 months and 1 year
Cost effectiveness
Time frame: 1 year
Cost utility
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Background: PubMed 25173339Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 19144937Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
- Background: PubMed 21232721Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.
- Background: PubMed 26347918Engstrom 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.
- Derived from this study: PubMed 38785084Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, Ngaleu Siaha F, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, Djadi-Prat J, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction. Circ Cardiovasc Interv. 2024 Jun;17(6):e013913. doi: 10.1161/CIRCINTERVENTIONS.123.013913. Epub 2024 May 24.
- Derived from this study: PubMed 34420366Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.
- Derived from this study: PubMed 33999545Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
- Derived from this study: PubMed 32000067Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.
- Individual participant dataSharing planned: Undecided
Related trials for Acute ST Segment Elevation Myocardial Infarction
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
Not yet recruiting
The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)
Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
Recruiting
Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction
Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)
Not yet recruiting
Prophylactic IABP in Delayed-Presentation Anterior STEMI
Acute Anterior ST-Segment Elevation Myocardial Infarction
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.
Etienne PUYMIRAT, MD principal investigator
AP - HP, Hôpital Europeen Georges-Pompidou, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography guided PCI and Fractional Flow Reserve (FFR) in people with Acute ST Segment Elevation Myocardial Infarction and Acute Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 9 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Rate of major adverse cardiac events (time frame: 1 year). 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 NCT02943954, which also lists 8 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 19 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.