Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393478
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-26
Brief Title:
Southeastern Europe Microcirculation Registry
Sponsor:
Institute for Cardiovascular Diseases Dedinje
Organization:
Institute for Cardiovascular Diseases Dedinje
Study Overview
Official Title:
Southeastern Europe Microcirculation Registry
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SATURATION
Brief Summary:
SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software Abbott Vascular Abbott Park IL USA and to assess the regional practice of patient selection cardiovascular outcomes and additional procedures stress testing angiography etc done after comprehensive invasive coronary physiology evaluation
Detailed Description:
The study will include adults of both sexes older than 18 years with angina symptoms or angina equivalent referred to cath lab for evaluation of coronary artery disease CAD that underwent invasive physiology testing performed microcirculation testing - vasospasm testing using Coroflow Coroventis Cardiovascular system Abbott Vascular Abbott Park IL USA The study will exclude persons under the age of 18 pregnant of nursing ant the ones where no coronary physiology measurements performed
The following data will be collected at enrollment
De-identified demographic data
Cardiovascular risk factors and significant co-morbidities
Laboratory investigations of interest
Prior cardiovascular events
Pre-procedure medications
Echocardiogram within 3 months of invasive coronary procedure
Non-invasive ischemia testing within 3 months of invasive coronary procedure
Seattle Angina Questionnaire SAQ
EQ-5D-5L
Details of the coronary angiography and invasive physiology procedure including procedural complications
Post-procedure medications
Data that will be collected during invasive coronary physiology testing
Vasospastic angina testing which artery what test result Microvascular angina testing which artery CFR IMR RRR FFR Pd Pa and all transit times
Patients will be seen at follow up visits and the following data will be collected every 6 months for up to 5 years
Major adverse cardiovascular events including repeat invasive coronary angiography since last follow up
Current medications
SAQ
EQ-5D-5L
Non-invasive ischemia testing since last follow up Outcomes will be evaluated every 6 months for 5 years via direct patient contact by research staff or at follow up visits Outcomes will be collected based on existing medical documentation
Primary outcomes
all-cause death and non-fatal MI
composite MACE all-cause death non-fatal MI coronary revascularization hospitalization for cardiovascular causes acute coronary syndrome heart failure angina repeated coronary angiography Secondary outcomes all-cause death cardiovascular death MI coronary revascularization stroke hospitalization for heart failure hospitalization for acute coronary syndrome repeated coronary angiography
Patient-centered outcomes
Freedom from angina SAQ questionnaire
Quality of life using EQ-5D-5L questionnaire
Follow up non-invasive ischemia testing if performed
The following data will be collected at enrollment
De-identified demographic data
Cardiovascular risk factors and significant co-morbidities
Laboratory investigations of interest
Prior cardiovascular events
Pre-procedure medications
Echocardiogram within 3 months of invasive coronary procedure
Non-invasive ischemia testing within 3 months of invasive coronary procedure
Seattle Angina Questionnaire SAQ
EQ-5D-5L
Details of the coronary angiography and invasive physiology procedure including procedural complications
Post-procedure medications
Data that will be collected during invasive coronary physiology testing
Vasospastic angina testing which artery what test result Microvascular angina testing which artery CFR IMR RRR FFR Pd Pa and all transit times
Patients will be seen at follow up visits and the following data will be collected every 6 months for up to 5 years
Major adverse cardiovascular events including repeat invasive coronary angiography since last follow up
Current medications
SAQ
EQ-5D-5L
Non-invasive ischemia testing since last follow up Outcomes will be evaluated every 6 months for 5 years via direct patient contact by research staff or at follow up visits Outcomes will be collected based on existing medical documentation
Primary outcomes
all-cause death and non-fatal MI
composite MACE all-cause death non-fatal MI coronary revascularization hospitalization for cardiovascular causes acute coronary syndrome heart failure angina repeated coronary angiography Secondary outcomes all-cause death cardiovascular death MI coronary revascularization stroke hospitalization for heart failure hospitalization for acute coronary syndrome repeated coronary angiography
Patient-centered outcomes
Freedom from angina SAQ questionnaire
Quality of life using EQ-5D-5L questionnaire
Follow up non-invasive ischemia testing if performed
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