Chronic Coronary SyndromeMultiInter-CCSNCT06261866
Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome
An observational study of Chronic Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 7 Apr 2011to 31 Dec 2028
- How long will I take part?
- 10 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: Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
Who may be able to join
- 18 years or older
- Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
- Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography
- FFR and OCT examination of the same lesion
- The patient is willing to participate in the study and has provided a written informed consent
Who cannot join
- Acute coronary syndrome
- Proximal left main lesion
- Ostial right coronary artery lesion
- Bypass of the assessed vessel
- Contraindications for adenosine administration
- Hemodynamic instability
Show all 9Show fewer
- Heart insufficiency in New York Heart Association (NYHA) class IV scale
- Acute renal insufficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mariusz Tomaniak contact
Piotr Baruś contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw
Mariusz Tomaniak, MD, PhD, Assoc. Prof., mariusz.tomaniak@wum.edu.pl
Piotr Baruś, MD, piotr.barus@wum.edu.pl
About this study
Official title: Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
Read the detailed description
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.
- Conditions
- Chronic Coronary Syndrome
- Keywords
- FFR, OCT, IVUS, CCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic coronary syndromes identified with intermediate grade coronary stenosis | Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR > 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Measured: Baseline
Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis
Measured: Baseline
Secondary outcomes (1)
Major adverse cardiovascular events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start7 Apr 2011
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
- Investigators
- Mariusz Tomaniak, MD, PhD, Assoc. Prof., Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261866
- Sponsor's protocol ID
- MultiInter-CCS
- Acronym
- MultiInter-CCS
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study
- ClinicalTrials.gov ID
- NCT06261866
- Acronym / sponsor ID
- MultiInter-CCS / MultiInter-CCS
- Conditions
- Chronic Coronary Syndrome
- Keywords
- FFR, OCT, IVUS, CCS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 7 Apr 2011 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Feb 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.
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
Detailed description
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic coronary syndromes identified with intermediate grade coronary stenosis | – | –Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR > 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
Key inclusion criteria (5 listed)
- 18 years or older
- Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
- Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography
- FFR and OCT examination of the same lesion
- The patient is willing to participate in the study and has provided a written informed consent
Key exclusion criteria (9 listed)
- Acute coronary syndrome
- Proximal left main lesion
- Ostial right coronary artery lesion
- Bypass of the assessed vessel
- Contraindications for adenosine administration
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
Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Time frame: Baseline
Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis
Time frame: Baseline
1 secondary outcome
Major adverse cardiovascular events
Time frame: 36 months
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 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Mariusz Tomaniak contact
Piotr Baruś contact
Mariusz Tomaniak, MD, PhD, Assoc. Prof. principal investigator
Medical University of Warsaw
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 Chronic Coronary Syndrome, run by Medical University of Warsaw 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 5 inclusion and 9 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 15 Feb 2024. 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?
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 Mariusz Tomaniak (mariusz.tomaniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis (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?
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 15 Feb 2024.