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Trial record 1 of 1 for:    FLOWER-MI
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FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction (FLOWER-MI)

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ClinicalTrials.gov Identifier: NCT02943954
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : November 19, 2021
Sponsor:
Collaborators:
Abbott
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 (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.


Condition or disease Intervention/treatment Phase
Acute ST Segment Elevation Myocardial Infarction Acute Myocardial Infarction Multi Vessel Coronary Artery Disease Procedure: Angiography guided PCI Device: Fractional Flow Reserve (FFR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 24, 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Angiography guided PCI
Revascularisation of non-culprit lesions guided by PCI
Procedure: Angiography guided PCI
FFR guided PCI
Revascularisation of non-culprit lesions guided by FFR measurement
Device: Fractional Flow Reserve (FFR)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Deaths [ Time Frame: 1 year ]
  2. Myocardial infarctions [ Time Frame: 1 year ]
  3. Repeat revascularizations [ Time Frame: 1 year ]
  4. Rate of nonculprit artery target lesion treated by urgent revascularization [ Time Frame: 1 year ]
  5. Rates of major adverse cardiac events at 30 days and 6 months [ Time Frame: 30 days and 6 months ]
  6. Rehospitalization for angina during the follow up period [ Time Frame: 1 year ]
  7. Procedure time [ Time Frame: 5 days ]
  8. Functional class at 1 year [ Time Frame: 1 year ]
    The functional class is assessed with the use of the Canadian Cardiovascular Society classification of angina.

  9. Health-related quality of life [ Time Frame: 1 year ]
    Health-related quality of life is assessed by the European Quality of Life-5 Dimensions [EQ-5D] questionnaires

  10. Anti-anginal medications used [ Time Frame: 1 month, 6 months and 1 year ]
    Number of anti-anginal medications used

  11. Cost effectiveness [ Time Frame: 1 year ]
    Incremental cost effectiveness ratio (ICER) using the composite endpoint (all-cause death, myocardial infarctions and repeat revascularizations).

  12. Cost utility [ Time Frame: 1 year ]
    Incremental cost-utility ration (ICUR) using quality-adjusted life years (QALYs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943954


Locations
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France
France
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Abbott
Ministry of Health, France
Investigators
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Principal Investigator: Etienne PUYMIRAT, MD AP - HP, Hôpital Europeen Georges-Pompidou, Paris, France
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02943954    
Other Study ID Numbers: P150943
2016-A00418-43 ( Other Identifier: Agence Nationale de Securite du Medicament et des Produits de Sante )
AOM15608 ( Other Grant/Funding Number: French Ministry of Health )
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fractional Flow Reserve
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases