Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT (OPTICO-LM)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    104
  • sponsor
    University Hospital Inselspital, Berne
Updated on 9 February 2022
angiography
computed tomography angiography
angina pectoris
stable angina
intravascular ultrasound
optical coherence tomography

Summary

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15m vs. 100m), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT.

This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR 0.8 as a reference standard.

Details
Condition Coronary Stenosis
Treatment OCT, FFR, CTA and FFRCT
Clinical Study IdentifierNCT03820492
SponsorUniversity Hospital Inselspital, Berne
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography
Age 18 years
Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures

Exclusion Criteria

Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])
Ostial LM disease
Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI)
LM In-stent restenosis
Previous coronary stenting of the left coronary system
Chronic total occlusion
Previous coronary artery bypass graft
Previous MI related to the left coronary artery
Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion
The presence of hemodynamic instability
Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis)
Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
Life expectancy less than 1 year
Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, -blocker, nitroglycerin, and adenosine
Body mass index >35kg/m2
Complex congenital heart disease other than anomalous coronary origins alone
Ventricular septal defect
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note