Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588244
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
INOCA-NA a Local Prospective Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ischemia in Patients with Non- Obstructive Disease INOCA - a Local Prospective Registry INOCA-Naples
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INOCA-NA
Brief Summary:
The present study has the following objectives
1 To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography CA co Division of Cardiology - Federico II University Hospital
2 To stratify in INOCA endotypes patients according to the presence or absence of alternative ie non obstructive CAD causes of myocardial ischemia detected during CA clinically indicated through physiology tests
3 to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up
1 To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography CA co Division of Cardiology - Federico II University Hospital
2 To stratify in INOCA endotypes patients according to the presence or absence of alternative ie non obstructive CAD causes of myocardial ischemia detected during CA clinically indicated through physiology tests
3 to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up
Detailed Description:
Eligible patients with angina andor positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows
Functional evaluation by fractional flow reserve FFR instantaneous wave-free ratio iFR Resting Full-Cycle Ratio RFR of any stenosis that is angio- graphically considered gt 50
In case of stenosis lt50 or gt50 but with negative functional evaluation FFR gt080 and iFRRFR
gt090 coronary flow reserve CFR and index of microvascular resistance IMR will be performed IMR and CFR will be evaluated using an intracoro- nary wire
In case of CFRgt20 and IMRlt25 acetylcholine test will be performed Intracoronary acetylcholine ACh will be administrated to detect epicardial fo- cal or diffuse or microvascular spasm
Functional evaluation by fractional flow reserve FFR instantaneous wave-free ratio iFR Resting Full-Cycle Ratio RFR of any stenosis that is angio- graphically considered gt 50
In case of stenosis lt50 or gt50 but with negative functional evaluation FFR gt080 and iFRRFR
gt090 coronary flow reserve CFR and index of microvascular resistance IMR will be performed IMR and CFR will be evaluated using an intracoro- nary wire
In case of CFRgt20 and IMRlt25 acetylcholine test will be performed Intracoronary acetylcholine ACh will be administrated to detect epicardial fo- cal or diffuse or microvascular spasm
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