Angina, MicrovascularSATURATIONNCT06393478
Southeastern Europe Microcirculation Registry
An observational study of Angina, Microvascular and Coronary Microvascular Dysfunction, run by Institute for Cardiovascular Diseases Dedinje at 10 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Microvascular, Coronary Microvascular Dysfunction, Coronary Artery Disease
- How many people
- 900 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 1 Mar 2024to 1 Mar 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Persons under the age of 18
- Pregnant of nursing
- No coronary physiology measurements performed
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
Greece4 sites, 4 recruiting
- Recruiting
MITERA General Hospital
Athens, 15123
Andreas Kalogeropoulos, MD., PhD, akalogeropoulos@mitera.gr
- Recruiting
Hippokration Hospital
Athens
Kyriakos Dimitriadis, MD, PhD, dimitriadiskyr@yahoo.gr
- Recruiting
Heraklion University Hospital
Heraklion
Michalis Hamilos, MD, PhD, xammix@hotmail.com
- Recruiting
University Hospital of Patras
Pátrai
Michail Papafaklis, MD, PhD, m.papafaklis@yahoo.com
Croatia2 sites, 2 recruiting
- Not yet recruiting
CHC Rijeka
Rijeka
Vjekoslav Tomulic, MD, vtomulic@gmail.com
- Not yet recruiting
KBC Zagreb
Zagreb
Hrvoje Jurin, MD, PhD, hrvoje.jurin@gmail.com
Serbia2 sites, 2 recruiting
- Recruiting
Institute for cardiovascular diseases Dedinje
Belgrade, 11040
Ivan Ilic, MD, PhD, +381641374455, ivan1ilic@yahoo.com
Natalija Odanovic, MD, +381641267902, natalija.odanovic@gmail.com
- Recruiting
Institute for cardiovascular diseases Vojvodine
Novi Sad, 21000
Milenko Cankovic, MD, PhD, milenko.cankovic@gmail.com
Igor Ivanov, MD, PhD, ivanovigor05@gmail.com
Israel1 site, 1 recruiting
- Not yet recruiting
Tel Aviv Sourasky MC
Tel Aviv
Maayan Konigstein, MD, PhD, maayan.konigstein@gmail.com
Slovenia1 site, 1 recruiting
- Not yet recruiting
UMC Ljubljana
Ljubljana
Matjaz Bunc, MD, PhD, mbuncek@yahoo.com
About this study
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.
Read the 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)
- Keywords
- microvascular angina, thermodilution, coronary flow reserve
- Medical subject headings
- Microvascular Angina, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death and non-fatal MI
The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure
Measured: 5 years
composite MACE
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)
Measured: 5 years
Secondary outcomes (8)
all-cause death
The study will record number of participants that died after invasive coronary physiology
Measured: 5 years
cardiovascular death
The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology
Measured: 5 years
myocardial infarction
The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology
Measured: 5 years
coronary revascularization
The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology
Measured: 5 years
stroke
The study will record the number of participants that suffered from stroke after invasive coronary physiology
Measured: 5 years
hospitalization for heart failure
The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology
Measured: 5 years
hospitalization for acute coronary syndrome
The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology
Measured: 5 years
repeated coronary angiography
The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina, MicrovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institute for Cardiovascular Diseases Dedinje
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Ivan Ilić, MD, PhD, Institute for Cardiovascular Diseases Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393478
- Sponsor's protocol ID
- IKVBD-KARD-001
- Acronym
- SATURATION
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. Cardiovasc Revasc Med. 2025 Sep;78:104-107. doi: 10.1016/j.carrev.2024.11.012. Epub 2024 Dec 6.
PubMed 39672766
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southeastern Europe Microcirculation Registry
- ClinicalTrials.gov ID
- NCT06393478
- Acronym / sponsor ID
- SATURATION / IKVBD-KARD-001
- Keywords
- microvascular angina, thermodilution, coronary flow reserve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Institute for Cardiovascular Diseases DedinjeUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2034 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Persons under the age of 18
- Pregnant of nursing
- No coronary physiology measurements performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 39672766Odanovic 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. Cardiovasc Revasc Med. 2025 Sep;78:104-107. doi: 10.1016/j.carrev.2024.11.012. Epub 2024 Dec 6.
Related trials for Angina, Microvascular
Active, not recruitingObservational study
The DISCOVER INOCA Prospective Multi-center Registry
Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction
RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Microvascular Angina
Not yet recruitingPhase 4
Coronary MicrovAscular Diseases Intervention With Compound Danshen Dropping Pills
Coronary Microvascular Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Not yet recruiting
Coronary Sinus Reducer Objective Impact on SymptoMs, Ischaemia and miCrovascular Resistance in Non-obstructive Hypertrophic CardioMyopathy
Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Microvascular and Coronary Microvascular Dysfunction, run by Institute for Cardiovascular Diseases Dedinje at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece, Croatia, Serbia, Israel, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan S Ilić, MD, PhD (+381641374455, ivan1ilic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death and non-fatal MI (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.