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Recruiting

NCT Number: NCT06393478

Southeastern Europe Microcirculation Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHC Rijeka, Rijeka, Croatia

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. all-cause death and non-fatal MI

    Time frame: 5 years

    The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure

  2. composite MACE

    Time frame: 5 years

    The study will record aggregate number of participants that died from any cause and/or experienced non-fatal myocardial infarction and/or coronary angioplasty procedure and/or hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography)

Secondary outcomes

  1. all-cause death

    Time frame: 5 years

    The study will record number of participants that died after invasive coronary physiology

  2. cardiovascular death

    Time frame: 5 years

    The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology

  3. myocardial infarction

    Time frame: 5 years

    The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology

  4. coronary revascularization

    Time frame: 5 years

    The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology

  5. stroke

    Time frame: 5 years

    The study will record the number of participants that suffered from stroke after invasive coronary physiology

  6. hospitalization for heart failure

    Time frame: 5 years

    The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology

  7. hospitalization for acute coronary syndrome

    Time frame: 5 years

    The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology

  8. repeated coronary angiography

    Time frame: 5 years

    The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan S Ilić, MD, PhD

CONTACT

[email protected]

+381641374455

Natalija Odanovic, MD

CONTACT

[email protected]

+381641267902

Sponsors and collaborators

Lead sponsor

Institute for Cardiovascular Diseases Dedinje

Other

Collaborators

  • Abbott Medical Devices

Registry information

Acronym: SATURATION

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
May 1, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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