Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02943954
Status:
UNKNOWN
Last Update Posted:
2021-11-19
First Post:
2016-09-07
Brief Title:
FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOWER-MI
Brief Summary:
Although current guidelines recommend fractional flow reserve FFR to identify haemodynamically relevant coronary lesions 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
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 lesions will be performed and only those lesions with a FFR 080 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
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 lesions will be performed and only those lesions with a FFR 080 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A00418-43 | OTHER | None | None |
| AOM15608 | OTHER_GRANT | French Ministry of Health | None |