CompletedNot Applicable

Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

France83 participantsStarted 2020-09-24

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose measured to the patient's skin at the entrance to the X-ray beam

Timeframe: 1 month

Trial details

NCT IDNCT05111496

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-16

View on ClinicalTrials.gov More X-rays; Effects trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.