Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-01 @ 3:19 AM
Study NCT ID:
NCT03910400
Status:
UNKNOWN
Last Update Posted:
2020-04-10
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Assessment of QFR in STEMI-II
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
EARLY Microvascular Dysfunction Assessment Using Quantitative Flow Ratio After ST-segment Elevation MYOcardial Infarction (EARLY-MYO-QFR II)
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
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:
EARLYmyoQFR-II
Brief Summary:
The study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study EARLY-MYO-QFR-I.
Detailed Description:
Microvascular dysfunction (MVD) is a serious complication of PCI, which happens frequently after STEMI and always correlates with a poor prognosis. However, precise and simplified assessment of MVD is difficult, especially in the acute phase of STEMI patients. Resent studies suggested that FFR could be overestimated when MVD exists. But whether the overestimated value of FFR caused by CMR defined microvascular obstruction (MVO) could reflect microvascular function is still unclear.
In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis.
This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.
In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis.
This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.
Study Oversight
Has Oversight DMC:
True
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?: