search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number22690
- NTR NumberNTR5376
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2015
- Secondary IDs15.0215n METC
- Public TitleCombined 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
- Scientific TitleCombined 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
- ACRONYMCOMBINE Registry
- hypothesisDiabetes 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Optical coherence tomography
- Inclusion criteria1. Age 18 years
2. History of DM with any indication for angiography (Stable Angina (SA) or any type of Acute Coronary Syndrome (ACS) including ST-Elevation MI).
3. 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).
- Exclusion criteria1. TIMI flow < 3 in the target lesion(s)
2. Target lesion reference diameter (on visual estimation) < 2.0 mm
3. Known left ventricular ejection fraction <30%
4. Known malignancy
5. Life expectancy < 2 years
6. Unwilling or unable to provide inform consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2015
- planned closingdate1-feb-2018
- Target number of participants500
- InterventionsDM 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 >65) (Group A) or TCFA (cap thickness ≤ 65) (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.
We strongly recommend that all major epicardial coronary vessels of stentable size that show any form of atherosclerosis to be interrogated with FFR and OCT.
- Primary outcomeThe 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).
- Secondary outcomeThe 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). 2) The per patient incidence composite MACE: Cardiac eath, 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).

3) 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 )
- TimepointsFirst patient in: feb 2015
Last patient in: aug 2016
Last patient out: feb 2018
Note: longer follow up will be performed if funding allows.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIES E. Kedhi
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Diagram B.V., St. Jude Medical
- Publications
- Brief summaryProspective, open label natural history registry. DM patients bearing target lesions 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 >65) (Group A) or TCFA (cap thickness ≤ 65) (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 plaque cap thickness as measured in the corelab will not be disclosed to operators and patients. This to study the natural evolution of , 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.
- Main changes (audit trail)
- RECORD11-aug-2015 - 26-aug-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl