Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685941
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2020-12-22
Brief Title:
Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Sponsor:
Fundación EPIC
Organization:
Fundación EPIC
Study Overview
Official Title:
Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
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:
RAIN FLOW
Brief Summary:
A total of 100 patients with ST-elevation myocardial infarction STEMI presenting slow-flow after primary-percutaneous coronary intervention PPCI will be randomized to pharmacologic treatment with hyperemic drugs versus flow-mediated hyperemia
Detailed Description:
Slow-flow phenomena is observed around 15 of patients undergoing PPCI and has been associated with poor prognosis Hyperemic drugs such as nitroprussiate and adenosine have not yet demonstrated to reduce the infarct size and prognosis in patients with slow flow Controlled flow-mediated hyperemia using a dedicated catheter for intracoronary saline infusion has been shown to stimulate microcirculatory vasodilatation in stable patients similarly as hyperemic drugs
The aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after PPCI as assessed by intracoronary thermo-dilution treated with standard pharmacologic hyperemia versus flow-mediated hyperemia and to compare the angiographic TIMI frame count after treatment of slow flow phenomena with the two investigated strategies
The aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after PPCI as assessed by intracoronary thermo-dilution treated with standard pharmacologic hyperemia versus flow-mediated hyperemia and to compare the angiographic TIMI frame count after treatment of slow flow phenomena with the two investigated strategies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None