X-rays; EffectsOptidoseNCT05111496
Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
An observational study of X-rays; Effects and Chronic Total Occlusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- X-rays; Effects, Chronic Total Occlusion
- What is being tested?
- Gafchromic film
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2020to 12 Apr 2023
- 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: Patient over 18 years-old, requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
Who may be able to join
- Patient over 18 years-old
- Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
- Patient benefiting from a social protection insurance
- Patient having been informed and not objecting to this research
Who cannot join
- Patient refusal to participate in the study
- Patient with known radiosensitivity factors (eg: Lupus)
- Patient having had radiotherapy treatment of the thoracic region.
- Patient whose sum of radiation doses to the skin> 0.5 Gy in the thoracic region in the 3 months preceding inclusion.
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding woman
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion
- Conditions
- X-rays; Effects, Chronic Total Occlusion
- Being tested
- Gafchromic film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gafchromic filmRadiation
Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation
| Study group | Role | What they receive |
|---|---|---|
| Patient requiring intervention (complex coronary dilation or coronary recanalization) | Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization Receives: Radiation: Gafchromic film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose measured to the patient's skin at the entrance to the X-ray beam
Dose expressed in Gy (Peak skin dose).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start24 Sep 2020
- Primary completion16 Dec 2022
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-rays; EffectsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111496
- Sponsor's protocol ID
- 2019-A02398-49
- Acronym
- Optidose
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
- ClinicalTrials.gov ID
- NCT05111496
- Acronym / sponsor ID
- Optidose / 2019-A02398-49
- Conditions
- X-rays; Effects, Chronic Total Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- 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.
The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient requiring intervention (complex coronary dilation or coronary recanalization) | – | Radiation: Gafchromic filmPatient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years-old, requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
Key inclusion criteria (4 listed)
- Patient over 18 years-old
- Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
- Patient benefiting from a social protection insurance
- Patient having been informed and not objecting to this research
Key exclusion criteria (8 listed)
- Patient refusal to participate in the study
- Patient with known radiosensitivity factors (eg: Lupus)
- Patient having had radiotherapy treatment of the thoracic region.
- Patient whose sum of radiation doses to the skin> 0.5 Gy in the thoracic region in the 3 months preceding inclusion.
- Patient participating in another clinical study
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 |
|---|---|---|
| Gafchromic filmBefore the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation | Radiation | Patient requiring intervention (complex coronary dilation or coronary recanalization) |
Primary outcome
Dose measured to the patient's skin at the entrance to the X-ray beam
Time frame: 1 month
Dose expressed in Gy (Peak skin dose).
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 16 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 X-rays; Effects and Chronic Total Occlusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 4 inclusion and 8 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 16 Jul 2026. 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 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?
Dose measured to the patient's skin at the entrance to the X-ray beam (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.