Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04808310
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2021-03-17
Brief Title:
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Status:
COMPLETED
Status Verified Date:
2024-10
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:
QUOMODO
Brief Summary:
The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome ACS treated with percutaneous coronary intervention PCI
Goals of the study are
To investigate whether decision-making based on quantitative flow reserve QFR is associated with a decrease in angina 3 months after an ACS
To investigate whether use of QFR is associated with an improved prognosis
Goals of the study are
To investigate whether decision-making based on quantitative flow reserve QFR is associated with a decrease in angina 3 months after an ACS
To investigate whether use of QFR is associated with an improved prognosis
Detailed Description:
The study is a single-center randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions
The primary analysis will be on the per-protocol principle ie including all patients who are not protocol violators A separate analysis will be performed on an intention-to-treat basis ie all randomized patients randomized to a treatment arm
Primary endpoint 1 Angina questionnaire
Secondary endpoints
Number and of patients undergoing PCI
Seattle Angina Questionnaire
SAQ Physical limitation scale
SAQ angina stability scale
SAQ angina frequency scale
SAQ quality of life
SAQ Treatment Satisfaction Disease perception scale Follow-up 3 and 12 months - Patient-oriented composite endpoint death myocardial infarction unplanned revascularization and its components
The primary analysis will be on the per-protocol principle ie including all patients who are not protocol violators A separate analysis will be performed on an intention-to-treat basis ie all randomized patients randomized to a treatment arm
Primary endpoint 1 Angina questionnaire
Secondary endpoints
Number and of patients undergoing PCI
Seattle Angina Questionnaire
SAQ Physical limitation scale
SAQ angina stability scale
SAQ angina frequency scale
SAQ quality of life
SAQ Treatment Satisfaction Disease perception scale Follow-up 3 and 12 months - Patient-oriented composite endpoint death myocardial infarction unplanned revascularization and its components
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