Coronary Artery DiseasePhase 4QUOMODONCT04808310
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
A Phase 4 study testing Quantitative flow ratio and Assessment of angiographic severity of the stenosis in people with Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Quantitative flow ratio and Assessment of angiographic severity of the stenosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 17 Apr 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successfully treated acute coronary syndrome
- At least one additional intermediate stenosis (>30% and <90%).
- Patient ≥18 years old
Who cannot join
- Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
- Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
- Any contraindication to PCI according to guidelines
- An ACS in the period following the index ACS and randomization
- TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
- Presence of thrombus in the non-culprit lesion
Show all 16Show fewer
- Participation in another randomized interventional study interfering with the present protocol
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
- Previous coronary artery bypass surgery CABG
- Recent (within 30 days) unsuccessful PCI
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- Left ventricular ejection fraction <30%
- Severe chronic obstructive pulmonary disease (COPD)
- Severe valvular heart disease
- FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
Goals of the study are:
- To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS
- To investigate whether use of QFR is associated with an improved prognosis.
Read the detailed description
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.
The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm).
Primary endpoint 1. Angina questionnaire
Secondary endpoints:
Number and % of patients undergoing PCI
Seattle Angina Questionnaire
- SAQ Physical limitation scale
- SAQ angina stability scale
- SAQ angina frequency scale
- SAQ quality of life
- SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.
- Conditions
- Coronary Artery Disease
- Being tested
- Quantitative flow ratio, Assessment of angiographic severity of the stenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative flow ratioDevice
Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA)
Assessment of angiographic severity of the stenosisDiagnostic test
The indication to coronary stent intervention will be based on angiography
| Study group | Role | What they receive |
|---|---|---|
| Angiography | Active comparator | The indication to further coronary intervention will be based on angiographic diameter stenosis. Receives: Diagnostic Test: Assessment of angiographic severity of the stenosis |
| Quantitative flow ratio (QFR) | Experimental | The indication to further coronary intervention will be based on QFR. Receives: Device: Quantitative flow ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oriented combined endpoint (clinical endpoint)
composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ<90)
Measured: 12 months
Functional endpoint
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
Measured: Upon randomization and following QFR assessment
Secondary outcomes (5)
Seattle angina questionaire summary score
Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))
Measured: 12 months
Seattle angina questionaire summary score
Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))
Measured: 3 months
Unplanned admission
Incidence of unplanned hospital admission for angina
Measured: 12 months
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Measured: 3 months
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Oct 2020
- Primary completion1 Apr 2023
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808310
- Sponsor's protocol ID
- 2020-15296
- Acronym
- QUOMODO
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ullrich-Daub H, Olschewski M, Schnorbus B, Belhadj KA, Kohler T, Vosseler M, Munzel T, Gori T. Quantitative flow ratio or angiography for the assessment of non-culprit lesions in acute coronary syndromes, a randomized trial. Clin Res Cardiol. 2025 Jun;114(6):729-737. doi: 10.1007/s00392-024-02484-5. Epub 2024 Jul 9.
PubMed 38980329Ullrich H, Olschewski M, Belhadj KA, Munzel T, Gori T. Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO. Front Cardiovasc Med. 2022 Apr 4;9:815434. doi: 10.3389/fcvm.2022.815434. eCollection 2022.
PubMed 35445090
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
- ClinicalTrials.gov ID
- NCT04808310
- Acronym / sponsor ID
- QUOMODO / 2020-15296
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 22 Mar 2021 (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 study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
Goals of the study are:
- To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS
- To investigate whether use of QFR is associated with an improved prognosis.
Detailed description
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.
The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm).
Primary endpoint 1. Angina questionnaire
Secondary endpoints:
Number and % of patients undergoing PCI
Seattle Angina Questionnaire
- SAQ Physical limitation scale
- SAQ angina stability scale
- SAQ angina frequency scale
- SAQ quality of life
- SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).
| Arm | Type | Receives |
|---|---|---|
| Angiography | Active comparator | Diagnostic Test: Assessment of angiographic severity of the stenosisThe indication to further coronary intervention will be based on angiographic diameter stenosis. |
| Quantitative flow ratio (QFR) | Experimental | Device: Quantitative flow ratioThe indication to further coronary intervention will be based on QFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successfully treated acute coronary syndrome
- At least one additional intermediate stenosis (>30% and <90%).
- Patient ≥18 years old
Key exclusion criteria (16 listed)
- Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
- Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
- Any contraindication to PCI according to guidelines
- An ACS in the period following the index ACS and randomization
- TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
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 |
|---|---|---|
| Quantitative flow ratioQuantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA) | Device | Quantitative flow ratio (QFR) |
| Assessment of angiographic severity of the stenosisThe indication to coronary stent intervention will be based on angiography | Diagnostic test | Angiography |
Primary outcome
Patient-oriented combined endpoint (clinical endpoint)
Time frame: 12 months
composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ<90)
Functional endpoint
Time frame: Upon randomization and following QFR assessment
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
5 secondary outcomes
Seattle angina questionaire summary score
Time frame: 12 months
Seattle angina questionaire summary score
Time frame: 3 months
Unplanned admission
Time frame: 12 months
Patient-oriented composite endpoint
Time frame: 3 months
Patient-oriented composite endpoint
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 38980329Ullrich-Daub H, Olschewski M, Schnorbus B, Belhadj KA, Kohler T, Vosseler M, Munzel T, Gori T. Quantitative flow ratio or angiography for the assessment of non-culprit lesions in acute coronary syndromes, a randomized trial. Clin Res Cardiol. 2025 Jun;114(6):729-737. doi: 10.1007/s00392-024-02484-5. Epub 2024 Jul 9.
- Derived from this study: PubMed 35445090Ullrich H, Olschewski M, Belhadj KA, Munzel T, Gori T. Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO. Front Cardiovasc Med. 2022 Apr 4;9:815434. doi: 10.3389/fcvm.2022.815434. eCollection 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quantitative flow ratio and Assessment of angiographic severity of the stenosis in people with Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 8 Oct 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-oriented combined endpoint (clinical endpoint) (time frame: 12 months). 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 NCT04808310, which also lists 2 linked publications.
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 8 Oct 2024.