Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06393478 |
| Other study ID # |
IKVBD-KARD-001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
March 1, 2034 |
Study information
| Verified date |
May 2024 |
| Source |
Institute for Cardiovascular Diseases "Dedinje" |
| Contact |
Ivan S Ilic, MD, PhD |
| Phone |
+381641374455 |
| Email |
ivan1ilic[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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)
