Clinical trial NCT06393478: Southeastern Europe Microcirculation Registry
Official title: Southeastern Europe Microcirculation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angina, Microvascular
Coronary Microvascular Dysfunction
Coronary Artery Disease
Keywords: microvascular angina, thermodilution, coronary flow reserve
Lead sponsor: Institute for Cardiovascular Diseases Dedinje
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2024-05-01
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients suffering from angina who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA).

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)

Eligibility criteria: Inclusion Criteria:

* Adults of both sexes older than 18 years
* Angina symptoms or angina equivalent
* Referred to Cath lab for evaluation of CAD
* Invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA)

Exclusion Criteria:

* Persons under the age of 18
* Pregnant of nursing
* No coronary physiology measurements performed

Primary outcomes:
measure: all-cause death and non-fatal MI
timeFrame: 5 years
measure: composite MACE
timeFrame: 5 years
Secondary outcomes:
measure: all-cause death
timeFrame: 5 years
measure: cardiovascular death
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: coronary revascularization
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
measure: hospitalization for heart failure
timeFrame: 5 years
measure: hospitalization for acute coronary syndrome
timeFrame: 5 years
measure: repeated coronary angiography
timeFrame: 5 years
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: CHC Rijeka
city: Zagreb
country: Croatia
facility: KBC Zagreb
city: Athens
country: Greece
facility: MITERA General Hospital
city: Athens
country: Greece
facility: Hippokration Hospital
city: Heraklion
country: Greece
facility: Heraklion University Hospital
city: Patras
country: Greece
facility: University Hospital of Patras
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC
city: Belgrade
country: Serbia
facility: Institute for cardiovascular diseases Dedinje
city: Novi Sad
country: Serbia
facility: Institute for cardiovascular diseases Vojvodine
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References: