Diabetes MellitusCOMBINENCT02989740
Optical Coherence Tomography Morphologic and Fractional Flow Reserve Assessment in Diabetes Mellitus Patients
An observational study of Diabetes Mellitus and Coronary Artery Disease, run by Diagram B.V. at 1 site in Netherlands.
Trial summary
Title: Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients COMBINE (OCT-FFR) Prospective Register To study the natural evolution of patients with at least one intermediate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Disease, Coronary Atheroscleroses
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 550 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Mar 2015to 28 Feb 2021
- How long will I take part?
- 18 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The COMBINE (OCT-FFR) Trial is an investigator driven study: a prospective natural history registry. Patients aged ≥ 18 years bearing target lesions (see definition section) that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study.
Who may be able to join
- Age ≥ 18 years
- History of DM with any indication for angiography (Stable Angina (SA) or any type of Acute Coronary Syndrome (ACS) including ST-Elevation MI).
- Coronary angiography, including FFR and OCT imaging of at least one coronary de novo stenosis in a native not-grafted vessel with a visually estimated diameter stenosis (DS) of ≥ 40 - ≤ 80% (target lesion) . Target lesion should be other than the culprit lesion(s) in patients presenting with MI (STEMI or non-STEMI).
Who cannot join
- TIMI flow < 3 in the target lesion(s)
- Target lesion reference diameter (on visual estimation) < 2.0 mm
- Known left ventricular ejection fraction <30%
- Known malignancy
- Life expectancy < 2 years
- Unwilling or unable to provide inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE (OCT-FFR) Prospective Register
Title:
Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients COMBINE (OCT-FFR) Prospective Register
To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.
Read the detailed description
Hypothesis Diabetes Mellitus (DM) patients with angiographically intermediate coronary lesions remain at risk for future MACE events, including those patients with fractional flow reserve (FFR) negative lesions. Use of FFR measurements combined with Optimal Coherence Tomography (OCT) detection of thin-cap fibroatheroma (TCFA) in will help predict future MACE rates.
Objective To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.
Design Prospective, open label natural history registry. DM patients bearing target lesions {Any de novo lesion with an angiographic visual estimation of ≥ 40%- ≤ 80% Diameter Stenosis (DS) that is located in a non-grafted coronary segment. In patients with an MI at presentation the target lesion should be different from the culprit lesion} and have undergone FFR and OCT imaging as for clinical routine will be prospectively enrolled and followed. Patients with negative FFR (> 0.80) will be divided in two categories depending on corelab OCT imaging findings: No-TCFA (cap thickness >65µ) (Group A) or TCFA (cap thickness ≤ 65µ) (group B). All patients that had a positive FFR and therefore have been treated with PCI as per standard care in all target lesions will also be followed (group C), however if after the PCI there is at least one remaining target lesion where FFR was negative these patients should be followed in group A or B depending on the OCT findings. Clinical endpoints at 1.5 year will be recorded.
The investigators strongly recommend that all major epicardial coronary vessels of stentable size that show any form of atherosclerosis to be interrogated with FFR and OCT.
The investigators strongly recommend to not perform cap thickness measurements in the cathlab. The plaque cap thickness as measured in the corelab will not be disclosed to operators and patients.
Population Patients aged ≥18 years Diabetes mellitus (DM) patients with any presentation. Coronary angiography, FFR and OCT imaging in at least one coronary de novo stenosis in a native vessel with a visually estimated diameter of stenosis (DS) of ≥ 40%-≤ 80% (target lesion).
Angiographic criteria target lesion:
(i) ≥ 40%-≤ 80% diameter stenosis (DS) (ii) de novo lesion located in native non-grafted vessel (iii) target lesion reference diameter of ≥ 2.0 mm (iv) TIMI 3 flow
Primary Endpoint The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B).
Statistics This is an observational study (prospective natural history register) where no randomization takes place, therefore a power calculation is strictly not necessary.
However, in order to observe meaningful differences between groups (as described in the design) and deduct founded conclusions, the minimal number of patients required was calculated as follows. The target lesion related primary endpoint at 18 months in the A and B group respectively are assumed to be 5 % and 20% respectively. Taking into account an expected loss in FU of 7%, a total of 500 patients enrolled in the study will provide 80% power to reject the null hypothesis with 5% type I error (alpha). The enrolment in group C will stop after the first 166 patients have been enrolled in this group. The rest of the rest of 334 patients will be distributed in groups A and B depending on the OCT corelab findings. Nul hypothesis: the MACE rate in group B is not different from group A.
- Being tested
- Optical Coherence Tomography
- Keywords
- Diabetes Mellitus, Thincap fibroatheroma, Optical Coherence Tomography, Fractional Flow Reserve
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyProcedure or surgery
Also called OCT
Patients aged ≥ 18 years bearing target lesions that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with negative FFR (> 0.80) in the target lesion \& decided on OCT (Optical Coherence Tomography) imaging findings with NO thin-cap fibroatheroma Receives: Procedure: Optical Coherence Tomography | |
| Group B | Patients with negative FFR (> 0.80) in the target lesion \& decided on OCT (Optical Coherence Tomography) imaging findings presence of ≥ thin-cap fibroatheroma Receives: Procedure: Optical Coherence Tomography | |
| Group C | Patients hosting FFR-positive target lesions that have been treated with PCI as per standard care and have further no TCFA lesions. Receives: Procedure: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The per patient incidence of the target lesion(s) related composite MACE
The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B).
Measured: 18 months after procedure
Secondary outcomes (3)
The per patient incidence of the target lesion(s) related composite MACE:
Cardicac death, MI, clinically- driven revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI-treated FFR-positive lesions (Group C).
Measured: 18 months after procedure
The per patient incidence composite MACE
The per patient incidence composite MACE: Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI treated FFR positive lesions (Group C).
Measured: 18 months after procedure
The incidence of MACE (Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina)
deriving from non PCI treated lesions between TCFA hosting patients anywhere in the major coronary of stentable size vs. patients with no TCFA (this analysis will be run in the total pool of patients after treatment of all FFR positive lesions and does not take in account the angiographic severity of the lesions ie. the location of the TCFA can be elsewhere than the target lesion )
Measured: 18 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start26 Mar 2015
- Primary completion30 Jun 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 550 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Isala, St. Jude Medical Nederland B.V.
- Responsible party
- Sponsor
- Investigators
- E Kedhi, MD PhD, Principal investigator, Erasmus Academical Hospital Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989740
- Sponsor's protocol ID
- 9241
- Acronym
- COMBINE
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kennedy MW, Fabris E, Ijsselmuiden AJ, Nef H, Reith S, Escaned J, Alfonso F, van Royen N, Wojakowski W, Witkowski A, Indolfi C, Ottervanger JP, Suryapranata H, Kedhi E. Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design. Cardiovasc Diabetol. 2016 Oct 10;15(1):144. doi: 10.1186/s12933-016-0464-8.
PubMed 27724869Kedhi E, Berta B, Roleder T, Hermanides RS, Fabris E, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Al Nooryani A, Rivero F, Malinowski K, De Luca G, Garcia Garcia H, Granada JF, Wojakowski W. Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial. Eur Heart J. 2021 Dec 1;42(45):4671-4679. doi: 10.1093/eurheartj/ehab433.
PubMed 34345911Wang Z, Kedhi E, Liu X, Li C, Huang J, Zhong J, Qu X, Wijns W, Tu S; COMBINE OCT-FFR Study Group. Prognostic Implications of Angiographically Derived Coronary Radial Wall Strain in Diabetic Patients and Non-Flow-Limiting Stenosis. JACC Cardiovasc Interv. 2025 May 26;18(10):1232-1242. doi: 10.1016/j.jcin.2025.02.009. Epub 2025 May 10.
PubMed 40347200Volleberg RHJA, Rroku A, Mol JQ, Hermanides RS, van Leeuwen M, Berta B, Meuwissen M, Alfonso F, Wojakowski W, Belkacemi A, Roleder T, Kedhi E, van Royen N; COMBINE (OCT-FFR) and PECTUS-obs investigators. FFR-Negative Nonculprit High-Risk Plaques and Clinical Outcomes in High-Risk Populations: An Individual Patient-Data Pooled Analysis From COMBINE (OCT-FFR) and PECTUS-obs. Circ Cardiovasc Interv. 2025 Feb;18(2):e014667. doi: 10.1161/CIRCINTERVENTIONS.124.014667. Epub 2025 Jan 22.
PubMed 39840429Del Val D, Berta B, Roleder T, Malinowski K, Bastante T, Hermanides RS, Wojakowski W, Fabris E, Cuesta J, De Luca G, Rivero F, Alfonso F, Kedhi E. Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial. EuroIntervention. 2024 Jun 3;20(11):e707-e717. doi: 10.4244/EIJ-D-23-00628.
PubMed 38840580Fabris E, Berta B, Hommels T, Roleder T, Hermanides RS, Rivero F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Roleder-Dylewska M, Gasior P, Malinowski KP, De Luca G, Garcia-Garcia HM, Granada JF, Wojakowski W, Kedhi E. Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma. EuroIntervention. 2023 Feb 6;18(13):e1099-e1107. doi: 10.4244/EIJ-D-22-00306.
PubMed 36170036Fabris E, Berta B, Roleder T, Hermanides RS, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Roleder-Dylewska M, Gasior P, Malinowski K, De Luca G, Garcia-Garcia HM, Granada JF, Wojakowski W, Kedhi E. Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT-FFR Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011728. doi: 10.1161/CIRCINTERVENTIONS.121.011728. Epub 2022 Apr 29.
PubMed 35485232
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE (OCT-FFR) Prospective Register
- ClinicalTrials.gov ID
- NCT02989740
- Acronym / sponsor ID
- COMBINE / 9241
- Keywords
- Diabetes Mellitus, Thincap fibroatheroma, Optical Coherence Tomography, Fractional Flow Reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Collaborators
- Isala, St. Jude Medical Nederland B.V.
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Dec 2016 (estimated)
- 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.
Title:
Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients COMBINE (OCT-FFR) Prospective Register
To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.
Detailed description
Hypothesis Diabetes Mellitus (DM) patients with angiographically intermediate coronary lesions remain at risk for future MACE events, including those patients with fractional flow reserve (FFR) negative lesions. Use of FFR measurements combined with Optimal Coherence Tomography (OCT) detection of thin-cap fibroatheroma (TCFA) in will help predict future MACE rates.
Objective To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.
Design Prospective, open label natural history registry. DM patients bearing target lesions {Any de novo lesion with an angiographic visual estimation of ≥ 40%- ≤ 80% Diameter Stenosis (DS) that is located in a non-grafted coronary segment. In patients with an MI at presentation the target lesion should be different from the culprit lesion} and have undergone FFR and OCT imaging as for clinical routine will be prospectively enrolled and followed. Patients with negative FFR (> 0.80) will be divided in two categories depending on corelab OCT imaging findings: No-TCFA (cap thickness >65µ) (Group A) or TCFA (cap thickness ≤ 65µ) (group B). All patients that had a positive FFR and therefore have been treated with PCI as per standard care in all target lesions will also be followed (group C), however if after the PCI there is at least one remaining target lesion where FFR was negative these patients should be followed in group A or B depending on the OCT findings. Clinical endpoints at 1.5 year will be recorded.
The investigators strongly recommend that all major epicardial coronary vessels of stentable size that show any form of atherosclerosis to be interrogated with FFR and OCT.
The investigators strongly recommend to not perform cap thickness measurements in the cathlab. The plaque cap thickness as measured in the corelab will not be disclosed to operators and patients.
Population Patients aged ≥18 years Diabetes mellitus (DM) patients with any presentation. Coronary angiography, FFR and OCT imaging in at least one coronary de novo stenosis in a native vessel with a visually estimated diameter of stenosis (DS) of ≥ 40%-≤ 80% (target lesion).
Angiographic criteria target lesion:
(i) ≥ 40%-≤ 80% diameter stenosis (DS) (ii) de novo lesion located in native non-grafted vessel (iii) target lesion reference diameter of ≥ 2.0 mm (iv) TIMI 3 flow
Primary Endpoint The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B).
Statistics This is an observational study (prospective natural history register) where no randomization takes place, therefore a power calculation is strictly not necessary.
However, in order to observe meaningful differences between groups (as described in the design) and deduct founded conclusions, the minimal number of patients required was calculated as follows. The target lesion related primary endpoint at 18 months in the A and B group respectively are assumed to be 5 % and 20% respectively. Taking into account an expected loss in FU of 7%, a total of 500 patients enrolled in the study will provide 80% power to reject the null hypothesis with 5% type I error (alpha). The enrolment in group C will stop after the first 166 patients have been enrolled in this group. The rest of the rest of 334 patients will be distributed in groups A and B depending on the OCT corelab findings. Nul hypothesis: the MACE rate in group B is not different from group A.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Optical Coherence TomographyPatients with negative FFR (> 0.80) in the target lesion \& decided on OCT (Optical Coherence Tomography) imaging findings with NO thin-cap fibroatheroma |
| Group B | – | Procedure: Optical Coherence TomographyPatients with negative FFR (> 0.80) in the target lesion \& decided on OCT (Optical Coherence Tomography) imaging findings presence of ≥ thin-cap fibroatheroma |
| Group C | – | Procedure: Optical Coherence TomographyPatients hosting FFR-positive target lesions that have been treated with PCI as per standard care and have further no TCFA lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The COMBINE (OCT-FFR) Trial is an investigator driven study: a prospective natural history registry. Patients aged ≥ 18 years bearing target lesions (see definition section) that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- History of DM with any indication for angiography (Stable Angina (SA) or any type of Acute Coronary Syndrome (ACS) including ST-Elevation MI).
- Coronary angiography, including FFR and OCT imaging of at least one coronary de novo stenosis in a native not-grafted vessel with a visually estimated diameter stenosis (DS) of ≥ 40 - ≤ 80% (target lesion) . Target lesion should be other than the culprit lesion(s) in patients presenting with MI (STEMI or non-STEMI).
Key exclusion criteria (6 listed)
- TIMI flow < 3 in the target lesion(s)
- Target lesion reference diameter (on visual estimation) < 2.0 mm
- Known left ventricular ejection fraction <30%
- Known malignancy
- Life expectancy < 2 years
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 |
|---|---|---|
| Optical Coherence TomographyAlso: OCTPatients aged ≥ 18 years bearing target lesions that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
The per patient incidence of the target lesion(s) related composite MACE
Time frame: 18 months after procedure
The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B).
3 secondary outcomes
The per patient incidence of the target lesion(s) related composite MACE:
Time frame: 18 months after procedure
The per patient incidence composite MACE
Time frame: 18 months after procedure
The incidence of MACE (Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina)
Time frame: 18 months after procedure
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 5 Sep 2021.
- Background: PubMed 27724869Kennedy MW, Fabris E, Ijsselmuiden AJ, Nef H, Reith S, Escaned J, Alfonso F, van Royen N, Wojakowski W, Witkowski A, Indolfi C, Ottervanger JP, Suryapranata H, Kedhi E. Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design. Cardiovasc Diabetol. 2016 Oct 10;15(1):144. doi: 10.1186/s12933-016-0464-8.
- Results publication: PubMed 34345911Kedhi E, Berta B, Roleder T, Hermanides RS, Fabris E, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Al Nooryani A, Rivero F, Malinowski K, De Luca G, Garcia Garcia H, Granada JF, Wojakowski W. Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial. Eur Heart J. 2021 Dec 1;42(45):4671-4679. doi: 10.1093/eurheartj/ehab433.
- Derived from this study: PubMed 40347200Wang Z, Kedhi E, Liu X, Li C, Huang J, Zhong J, Qu X, Wijns W, Tu S; COMBINE OCT-FFR Study Group. Prognostic Implications of Angiographically Derived Coronary Radial Wall Strain in Diabetic Patients and Non-Flow-Limiting Stenosis. JACC Cardiovasc Interv. 2025 May 26;18(10):1232-1242. doi: 10.1016/j.jcin.2025.02.009. Epub 2025 May 10.
- Derived from this study: PubMed 39840429Volleberg RHJA, Rroku A, Mol JQ, Hermanides RS, van Leeuwen M, Berta B, Meuwissen M, Alfonso F, Wojakowski W, Belkacemi A, Roleder T, Kedhi E, van Royen N; COMBINE (OCT-FFR) and PECTUS-obs investigators. FFR-Negative Nonculprit High-Risk Plaques and Clinical Outcomes in High-Risk Populations: An Individual Patient-Data Pooled Analysis From COMBINE (OCT-FFR) and PECTUS-obs. Circ Cardiovasc Interv. 2025 Feb;18(2):e014667. doi: 10.1161/CIRCINTERVENTIONS.124.014667. Epub 2025 Jan 22.
- Derived from this study: PubMed 38840580Del Val D, Berta B, Roleder T, Malinowski K, Bastante T, Hermanides RS, Wojakowski W, Fabris E, Cuesta J, De Luca G, Rivero F, Alfonso F, Kedhi E. Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial. EuroIntervention. 2024 Jun 3;20(11):e707-e717. doi: 10.4244/EIJ-D-23-00628.
- Derived from this study: PubMed 36170036Fabris E, Berta B, Hommels T, Roleder T, Hermanides RS, Rivero F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Roleder-Dylewska M, Gasior P, Malinowski KP, De Luca G, Garcia-Garcia HM, Granada JF, Wojakowski W, Kedhi E. Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma. EuroIntervention. 2023 Feb 6;18(13):e1099-e1107. doi: 10.4244/EIJ-D-22-00306.
- Derived from this study: PubMed 35485232Fabris E, Berta B, Roleder T, Hermanides RS, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Roleder-Dylewska M, Gasior P, Malinowski K, De Luca G, Garcia-Garcia HM, Granada JF, Wojakowski W, Kedhi E. Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT-FFR Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011728. doi: 10.1161/CIRCINTERVENTIONS.121.011728. Epub 2022 Apr 29.
- Cardiovascular DiabetologyLink provided by the sponsor.
- 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.
E Kedhi, MD PhD principal investigator
Erasmus Academical Hospital Brussels
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 Diabetes Mellitus and Coronary Artery Disease, run by Diagram B.V. at 1 site in Netherlands.
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 6 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 5 Sep 2021. 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 Netherlands. 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?
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?
The per patient incidence of the target lesion(s) related composite MACE (time frame: 18 months after procedure). 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 NCT02989740, which also lists 7 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 5 Sep 2021.