Southeastern Europe Microcirculation Registry

Last updated: May 12, 2024
Sponsor: Institute for Cardiovascular Diseases "Dedinje"
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Vascular Diseases

Angina

Treatment

N/A

Clinical Study ID

NCT06393478
IKVBD-KARD-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 +/- vasospasmtesting) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, AbbottPark, IL, USA)

Exclusion

Exclusion Criteria:

  • Persons under the age of 18

  • Pregnant of nursing

  • No coronary physiology measurements performed

Study Design

Total Participants: 900
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2034

Study 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)

Connect with a study center

  • CHC Rijeka

    Rijeka,
    Croatia

    Site Not Available

  • KBC Zagreb

    Zagreb,
    Croatia

    Site Not Available

  • Hippokration Hospital

    Athens,
    Greece

    Active - Recruiting

  • MITERA General Hospital

    Athens, 15123
    Greece

    Active - Recruiting

  • Heraklion University Hospital

    Heraklion,
    Greece

    Active - Recruiting

  • University Hospital of Patras

    Patras,
    Greece

    Active - Recruiting

  • Tel Aviv Sourasky MC

    Tel Aviv,
    Israel

    Site Not Available

  • Institute for cardiovascular diseases Dedinje

    Belgrade, 11040
    Serbia

    Active - Recruiting

  • Institute for cardiovascular diseases Vojvodine

    Novi Sad, 21000
    Serbia

    Active - Recruiting

  • UMC Ljubljana

    Ljubljana,
    Slovenia

    Site Not Available

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