Clinical trial NCT01743274: Does Optical Coherence Tomography Optimise Results of Stenting
Official title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: acute coronary syndromes
non-ST elevation myocardial infarction
angioplasty
fractional flow reserve
optical coherence tomography
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.


Eligibility criteria: Inclusion Criteria:

Patients aged 18 to 80 years inclusive, admitted for acute coronary syndrome (ACS) with the following symptoms :

* Clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours;
* AND at least one of the following two criteria :

  * New ST segment depression ≥1 mm or transitory ST segment elevation (\<30 minutes) (≥1 mm) on at least 2 contiguous leads of the ECG; OR
  * Elevation (\>upper limit of normal, ULN) of cardiac enzymes (CK-MB, Troponin I or T).

AND Presenting an indication for coronary angioplasty with stent implantation of the target lesion considered to be responsible for the ACS.

AND Written informed consent.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from the study:

* Left main stem disease
* Presence of coronary artery bypass grafts
* Cardiogenic shock or severe hemodynamic instability
* Severely calcified or tortuous arteries
* Persistent ST segment elevation
* One or more other lesions considered angiographically significant and located on the target vessel
* Severe renal insufficiency (creatinine clearance ≤30 mL/min)
* Bacteraemia or septicaemia
* Severe coagulation disorders
* Patients who refuse to sign the informed consent form

Primary outcomes:
measure: Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
timeFrame: Measured at the end of the angioplasty procedure
Secondary outcomes:
measure: Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
timeFrame: Assessed during the initial angioplasty procedure (Day 0)
measure: Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images
timeFrame: During the initial angioplasty procedure, as soon as the operator decides whether or not to proceed with additional interventions based on OCT data (Day 0)
measure: Safety of OCT in the context of angioplasty for ACS
timeFrame: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)
measure: Adverse cardiac events at 6 months
timeFrame: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty
measure: Determination of a threshold value for quantitative OCT measures (i.e. minimal lumen diameter and minimal lumen area) that best predict a fractional flow reserve value >=0.90.
timeFrame: At the end of the initial angioplasty procedure (Day 0)
measure: Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict FFR as measured at the end of the initial angioplasty procedure.
timeFrame: At the end of the initial angioplasty procedure (Day 0)
measure: Comparison between online and offline analyses of OCT data
timeFrame: Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)
Other outcomes:
Locations:
city: Annecy
country: France
facility: Annecy Hospital
state: Metz-Tessy
city: Belfort
country: France
facility: Centre Hospitalier
city: Besancon
country: France
facility: University Hospital Jean Minjoz
city: Chambéry
country: France
facility: Centre Hospitalier de Chambery
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Lille
country: France
facility: Centre Hospitalier Universitaire Régional
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
Study officials:
affiliation: University Hospital Besancon, France
name: Nicolas F. Meneveau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meneveau N, Ecarnot F, Souteyrand G, Motreff P, Caussin C, Van Belle E, Ohlmann P, Morel O, Grentzinger A, Angioi M, Chopard R, Schiele F. Does optical coherence tomography optimize results of stenting? Rationale and study design. Am Heart J. 2014 Aug;168(2):175-81.e1-2. doi: 10.1016/j.ahj.2014.05.007. Epub 2014 May 24.
citation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.
citation: Meneveau N, Ecarnot F. Response by Meneveau and Ecarnot to Letter Regarding Article, "Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)". Circulation. 2017 Feb 28;135(9):e142-e143. doi: 10.1161/CIRCULATIONAHA.116.026277. No abstract available.