Acute Coronary SyndromesDOCTORSNCT01743274
Does Optical Coherence Tomography Optimise Results of Stenting
A study testing OCT in people with Acute Coronary Syndromes, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- OCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2012to Aug 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Annecy Hospital
Annecy, Metz-Tessy, 74370
Centre Hospitalier
Belfort, 90000
University Hospital Jean Minjoz
Besançon, 25000
Centre Hospitalier de Chambery
Chambéry, 73000
Hôpital Gabriel Montpied
Clermont-Ferrand
Centre Hospitalier Universitaire Régional
Lille
Institut Mutualiste Montsouris
Paris
Nouvel Hôpital Civil
Strasbourg, 67000
About this study
Official title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- OCT
- Keywords
- acute coronary syndromes, non-ST elevation myocardial infarction, angioplasty, fractional flow reserve, optical coherence tomography
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTProcedure or surgery
Also called Optical coherence tomography
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.
OCT images are acquired by automated pullback over 2 to 3 seconds of the light source that yields a helicoidal image of a longitudinal segment of 50 mm. Intravascular imaging is obtained by injecting contrast medium or saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Randomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups. In the "Control" Group, the angioplasty procedure will be guided by traditional fluoroscopy alone. In both groups, fractional flow reserve (FFR) will be measured at the end of the procedure, once the operator considers the result of the angioplasty to be optimal. The average of three consecutive FFR measures will be recorded. |
| Optical Coherence Tomography | Experimental | Randomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups.
In the "OCT" group, OCT will be performed to optimise the results of angioplasty. The procedure will be performed according to usual practice, with or without pre-dilation before implantation of one or more stents (drug-eluting or bare metal). In the OCT group, OCT will be performed after initial coronary angiography and at the end of the procedure and the operator will have the possibility to change procedural strategy according to the data immediately available on the OCT images, with the possibility of additional interventions (additional balloon inflations, addition stent implantation, use of GPIIb/IIIa inhibitors and/or thromboaspiration and/or rotational atherectomy). Receives: Procedure: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
Evaluation of the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) at the end of the procedure.
The average of three consecutive FFR measures will be recorded.
Measured: Measured at the end of the angioplasty procedure
Secondary outcomes (7)
Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
Assessed by the presence of any one or more of the following criteria:
Incomplete coverage of the lesion by the stent, Residual stenosis upstream or downstream from the stent, Edge dissection, Presence of thrombus, Tissue protrusion through the stent struts, Stent Malapposition.
Measured: Assessed during the initial angioplasty procedure (Day 0)
Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images
Any one or more of the following criteria based on the information obtained from OCT images:
Diameter and length of implanted stents Supplementary balloon inflations Implantation of supplementary stent(s) Use of glycoprotein (GP) IIb/IIIa inhibitors Use of thrombo-aspiration Use of rotational atherectomy
Measured: 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)
Safety of OCT in the context of angioplasty for ACS
Safety as assessed by the following criteria:
- Duration of the procedure
- Fluoroscopy time
- Quantity of contrast medium used
- Procedural complications (no reflow, coronary perforation, occlusive dissection, spasm, stent occlusion, troponin peak at 24 hours, creatinine clearance at 24 hours)
Measured: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)
Adverse cardiac events at 6 months
Any one or more of the following:
- Death
- Recurrent MI
- Stent thrombosis
- Repeat revascularisation of the target vessel
Measured: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty
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.
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 (FFR) value >=0.90.
Measured: At the end of the initial angioplasty procedure (Day 0)
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.
Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict the value of fractional flow reserve as measured at the end of the initial angioplasty procedure on day 0.
Measured: At the end of the initial angioplasty procedure (Day 0)
Comparison between online and offline analyses of OCT data
Comparison between results of online and offline analyses of OCT data.
Measured: Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas F. Meneveau, MD, Principal investigator, University Hospital Besancon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743274
- Sponsor's protocol ID
- P/2012/141
- Acronym
- DOCTORS
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2012
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25066556Meneveau 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.
PubMed 27573032Meneveau 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.
PubMed 28242645
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study
- ClinicalTrials.gov ID
- NCT01743274
- Acronym / sponsor ID
- DOCTORS / P/2012/141
- Conditions
- Acute Coronary Syndromes
- Keywords
- acute coronary syndromes, non-ST elevation myocardial infarction, angioplasty, fractional flow reserve, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Dec 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Randomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups. In the "Control" Group, the angioplasty procedure will be guided by traditional fluoroscopy alone. In both groups, fractional flow reserve (FFR) will be measured at the end of the procedure, once the operator considers the result of the angioplasty to be optimal. The average of three consecutive FFR measures will be recorded. |
| Optical Coherence Tomography | Experimental | Procedure: OCTRandomization will be performed after initial coronary angiography, once the operator has identified the lesion responsible for the ACS. Patients will be randomly allocated to one of two groups. In the "OCT" group, OCT will be performed to optimise the results of angioplasty. The procedure will be performed according to usual practice, with or without pre-dilation before implantation of one or more stents (drug-eluting or bare metal). In the OCT group, OCT will be performed after initial coronary angiography and at the end of the procedure and the operator will have the possibility to change procedural strategy according to the data immediately available on the OCT images, with the possibility of additional interventions (additional balloon inflations, addition stent implantation, use of GPIIb/IIIa inhibitors and/or thromboaspiration and/or rotational atherectomy). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 :
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| OCTAlso: Optical coherence tomographyOptical 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. OCT images are acquired by automated pullback over 2 to 3 seconds of the light source that yields a helicoidal image of a longitudinal segment of 50 mm. Intravascular imaging is obtained by injecting contrast medium or saline solution. | Procedure or surgery | Optical Coherence Tomography |
Primary outcome
Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)
Time frame: Measured at the end of the angioplasty procedure
Evaluation of the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) at the end of the procedure. The average of three consecutive FFR measures will be recorded.
7 secondary outcomes
Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty
Time frame: Assessed during the initial angioplasty procedure (Day 0)
Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images
Time frame: 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)
Safety of OCT in the context of angioplasty for ACS
Time frame: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)
Adverse cardiac events at 6 months
Time frame: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty
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.
Time frame: At the end of the initial angioplasty procedure (Day 0)
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.
Time frame: At the end of the initial angioplasty procedure (Day 0)
Comparison between online and offline analyses of OCT data
Time frame: Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)
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 21 Nov 2017.
- Background: PubMed 25066556Meneveau 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.
- Results publication: PubMed 27573032Meneveau 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.
- Results publication: PubMed 28242645Meneveau 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.
Related trials for Acute Coronary Syndromes
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
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.
Nicolas F. Meneveau, MD principal investigator
University Hospital Besancon, France
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT in people with Acute Coronary Syndromes, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
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 7 inclusion and 11 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) (time frame: Measured at the end of the angioplasty 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 NCT01743274, which also lists 3 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 21 Nov 2017.