Southeastern Europe Microcirculation Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Angina, Microvascular, Coronary Microvascular Dysfunction, Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia, Greece, Israel, Serbia, Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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)
Primary outcome measures
- all-cause death and non-fatal MI [Time frame: 5 years]
- composite MACE [Time frame: 5 years]
Secondary outcome measures (8)
- all-cause death [Time frame: 5 years]
- cardiovascular death [Time frame: 5 years]
- myocardial infarction [Time frame: 5 years]
- coronary revascularization [Time frame: 5 years]
- stroke [Time frame: 5 years]
- hospitalization for heart failure [Time frame: 5 years]
- hospitalization for acute coronary syndrome [Time frame: 5 years]
- repeated coronary angiography [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 4 centers
- MITERA General Hospital — Athens
- Hippokration Hospital — Athens
- Heraklion University Hospital — Heraklion
- University Hospital of Patras — Pátrai
Croatia · 2 centers
- CHC Rijeka — Rijeka
- KBC Zagreb — Zagreb
Serbia · 2 centers
- Institute for cardiovascular diseases Dedinje — Belgrade
- Institute for cardiovascular diseases Vojvodine — Novi Sad
Israel · 1 center
- Tel Aviv Sourasky MC — Tel Aviv
Slovenia · 1 center
- UMC Ljubljana — Ljubljana
Publications
- Odanovic N, Tsioufis K, Dimitriadis K, Sakalidis A, Papafaklis MI, Davlouros P, Ivanov I, Cankovic M, Kalogeropoulos AS, Hamilos M, Sideras E, Konigstein M, Zornitzki L, Kovarnik T, Ruzsa Z, Piroth Z, Zdravkovic M, Mehmedbegovic Z, Miovski Z, Jurin H, Kanovsky J, Regev E, Shah S, Ilic I; SATURATION investigators. SoutheAsTern eUrope microciRculATION (SATURATION) registry - Design and rationale. Ca PMID 39672766
Identifiers
NCT: NCT06393478 · IKVBD-KARD-001