Coronary Artery DiseaseMOSAIC-CORNCT05313919
Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis
An observational study of Coronary Artery Disease and Ischemia and No Obstructive Coronary Arteries, run by Bartlomiej Guzik at 1 site in Poland.
Trial summary
Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Ischemia and No Obstructive Coronary Arteries, Ischemic Heart Disease
- What is being tested?
- Comprehensive functional diagnostics of coronary circulation
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 24 Jul 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.
Who may be able to join
- Diagnosed chronic coronary syndrome CCS ≥ 2.
- Evidence of myocardial ischemia (positive result of non-invasive stress test).
- Informed consent.
- Age at least 18 years.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, 31-202
Krzysztof Pazdan, +48 12 614 25 85, k.pazdan@szpitaljp2.krakow.pl
Paweł Kleczyński, MD, PhD
About this study
Official title: Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.
Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.
- Conditions
- Coronary Artery Disease, Ischemia and No Obstructive Coronary Arteries, Ischemic Heart Disease, Microvascular Angina, Vasospastic Angina
- Being tested
- Comprehensive functional diagnostics of coronary circulation
- Keywords
- coronary artery disease, ischemia and no obstructive coronary arteries, ischemic heart disease, microvascular angina, vasospastic angina, coronary microvascular dysfunction, coronary microcirculation, endothelial dysfunction
- Medical subject headings
- Coronary Artery Disease, Ischemia, Myocardial Ischemia, Microvascular Angina, Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive functional diagnostics of coronary circulationDiagnostic test
Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including:
- echocardiography with assessment of diastolic function
- flow-mediated dilation of brachial artery
- coronary angiography
- functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau)
- provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm)
- laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level)
- serum level of inflammatory cytokines and chemokines
| Study group | Role | What they receive |
|---|---|---|
| 1. Coronary microcirculatory disease | Not described Receives: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation | |
| 2. Epicardial vasospastic angina | Not described Receives: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation | |
| 3. Microvessel vasospastic angina | Not described Receives: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation | |
| 4. Non-cardiac disorder | Not described Receives: Diagnostic Test: Comprehensive functional diagnostics of coronary circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines (serum levels)
Measured: baseline
Diastolic Disfunction parameters in ECHO
Measured: baseline, 12- and 24-month follow-up
Secondary outcomes (4)
MACCE occurrence
Measured: baseline, 12- and 24-month observation
Hospitalization any
Measured: baseline, 12- and 24-month observation
symptoms intensity and quality of life (questionnaires)
Measured: baseline, 12- and 24-month observation
FMD
Measured: baseline, 12- and 24-month observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start24 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (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 Coronary Artery DiseaseStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartlomiej Guzik
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Bartlomiej Guzik, John Paul II Hospital, Krakow
- Investigators
- Bartłomiej Guzik, MD, PhD, Principal investigator, John Paul II Hospital, Krakow, PolandJacek Legutko, MD, PhD, Professor, Study director, John Paul II Hospital, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313919
- Sponsor's protocol ID
- 304/KBL/OIL2019
- Other IDs
- PL-2020-01
- Acronym
- MOSAIC-COR
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stapor M, Bernacik A, Szolc P, Niewiara L, Guzik B, Kleczynski P, Diachyshyn M, Zmudka K, Legutko J. Prevalence of heart failure with preserved ejection fraction in patients with ischemia and non-obstructive coronary arteries. Sci Rep. 2026 Mar 13;16(1):16626. doi: 10.1038/s41598-026-42032-x.
PubMed 41826400
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.
- ClinicalTrials.gov ID
- NCT05313919
- Acronym / sponsor ID
- MOSAIC-COR / 304/KBL/OIL2019
- Conditions
- Coronary Artery Disease, Ischemia and No Obstructive Coronary Arteries, Ischemic Heart Disease, Microvascular Angina, Vasospastic Angina
- Keywords
- coronary artery disease, ischemia and no obstructive coronary arteries, ischemic heart disease, microvascular angina, vasospastic angina, coronary microvascular dysfunction, coronary microcirculation, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Bartlomiej GuzikUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Apr 2022 (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.
Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Coronary microcirculatory disease | – | Diagnostic Test: Comprehensive functional diagnostics of coronary circulation |
| 2. Epicardial vasospastic angina | – | Diagnostic Test: Comprehensive functional diagnostics of coronary circulation |
| 3. Microvessel vasospastic angina | – | Diagnostic Test: Comprehensive functional diagnostics of coronary circulation |
| 4. Non-cardiac disorder | – | Diagnostic Test: Comprehensive functional diagnostics of coronary circulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.
Key inclusion criteria (4 listed)
- Diagnosed chronic coronary syndrome CCS ≥ 2.
- Evidence of myocardial ischemia (positive result of non-invasive stress test).
- Informed consent.
- Age at least 18 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive functional diagnostics of coronary circulationComprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including: * echocardiography with assessment of diastolic function * flow-mediated dilation of brachial artery * coronary angiography * functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau) * provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm) * laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level) * serum level of inflammatory cytokines and chemokines | Diagnostic test | 1. Coronary microcirculatory disease, 2. Epicardial vasospastic angina, 3. Microvessel vasospastic angina, 4. Non-cardiac disorder |
Primary outcome
Cytokines (serum levels)
Time frame: baseline
Diastolic Disfunction parameters in ECHO
Time frame: baseline, 12- and 24-month follow-up
4 secondary outcomes
MACCE occurrence
Time frame: baseline, 12- and 24-month observation
Hospitalization any
Time frame: baseline, 12- and 24-month observation
symptoms intensity and quality of life (questionnaires)
Time frame: baseline, 12- and 24-month observation
FMD
Time frame: baseline, 12- and 24-month observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 41826400Stapor M, Bernacik A, Szolc P, Niewiara L, Guzik B, Kleczynski P, Diachyshyn M, Zmudka K, Legutko J. Prevalence of heart failure with preserved ejection fraction in patients with ischemia and non-obstructive coronary arteries. Sci Rep. 2026 Mar 13;16(1):16626. doi: 10.1038/s41598-026-42032-x.
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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. This study is not recruiting at the moment.
Bartłomiej Guzik, MD, PhD principal investigator
John Paul II Hospital, Krakow, Poland
Jacek Legutko, MD, PhD, Professor study director
John Paul II Hospital, Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemia and No Obstructive Coronary Arteries, run by Bartlomiej Guzik at 1 site in Poland.
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 0 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartłomiej Guzik, MD, PhD (+48 614 35 01, b.guzik@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (serum levels) (time frame: baseline). 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 NCT05313919, 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 6 Apr 2022.