Radiation ExposureDOSENCT04023838
Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach
A study testing artery puncture and coronary angiography in people with Radiation Exposure and Vascular Access Complication, run by Chonnam National University Hospital.
Trial summary
Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure, Vascular Access Complication, Radial Artery Injury
- What is being tested?
- artery puncture and coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are a palpable right radial artery and left distal radial artery
- The decision to participate voluntarily in this study and the written consent of the patient
Who cannot join
- Patients who are not palpable right radial artery and left distal radial artery
- Patients who have arteriovenous fistula
- Patients presenting with acute myocardial infarction
- Patients who need to perform coronary angiography via femoral approach, such as shock state
- Patients who have atrioventricular block on the electrocardiogram
- Patients who have a plan to perform Ergonovine provocation test
- Patients who need percutaneous coronary intervention
- Patients who are not appropriate for this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial
Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach
Read the detailed description
The left snuffbox approach is expected to be easier to perform because of less severe tortuosity of the clavicle artery. However, clinical validation of the snuffbox approach was not completed compared with the conventional radial approach. Especially, there is no clinical data on the comparison of the radiation dose in both approaches. To date, there have been some studies on the radiation dose between the left and right radial artery and femoral artery puncture site, but no studies have been conducted on the left snuffbox approach.
The purpose of this study was to compare the radiation doses of the two interventional radiologists by randomly assigning coronary angiography to the left snuffbox approach and right conventional radial approach.
- Being tested
- artery puncture and coronary angiography
- Keywords
- Radiation, Snuffbox approach, Radial approach, Vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artery puncture and coronary angiographyProcedure or surgery
We will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea).
| Study group | Role | What they receive |
|---|---|---|
| Right conventional radial approach | Placebo comparator | After local anesthesia on right wrist area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). Receives: Procedure: artery puncture and coronary angiography |
| Left distal radial approach | Active comparator | After local anesthesia on left anatomical snuffbox area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). Receives: Procedure: artery puncture and coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose of the operator (µSv)
Radiation dose (µSv) of the operator's head, hand, and body will be compared between right conventional radial artery approach and left snuffbox approach group.
Measured: Through procedure completion, up to 6 hours
Secondary outcomes (6)
Fluoroscopy time for coronary angiography (second)
Fluoroscopy time (second) will be compared between two groups during coronary angiography.
Measured: Through procedure completion, up to 6 hours
Dose-area product (mGy*cm2)
Dose-area product (DAP) (mGy*cm2) will be compared between two groups during coronary angiography.
Measured: Through procedure completion, up to 6 hours
Success rate of radial puncture (%)
Successful introduction of sheath (%)
Measured: Through procedure completion, up to 6 hours
Cannulation time (second)
Time from local anesthesia to sheath cannulation (second)
Measured: Through procedure completion, up to 6 hours
Hemostasis duration (minute)
Hemostasis (minute) is obtained by compressive bandage with ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea)
Measured: During hospitalization, up to 1 month
Puncture site complication after hemostasis
Evaluation of puncture-site bleeding complication using EASY criteria
Measured: During hospitalization, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized either conventional right radial approach or left distal radial approach.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Ho Jeong, Chonnam National University Hospital
- Investigators
- Yongcheol Kim, MD, Study director, Department of Cardiology, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023838
- Sponsor's protocol ID
- DOSE
- Acronym
- DOSE
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial
- ClinicalTrials.gov ID
- NCT04023838
- Acronym / sponsor ID
- DOSE / DOSE
- Keywords
- Radiation, Snuffbox approach, Radial approach, Vascular access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Jul 2019 (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.
Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach
Detailed description
The left snuffbox approach is expected to be easier to perform because of less severe tortuosity of the clavicle artery. However, clinical validation of the snuffbox approach was not completed compared with the conventional radial approach. Especially, there is no clinical data on the comparison of the radiation dose in both approaches. To date, there have been some studies on the radiation dose between the left and right radial artery and femoral artery puncture site, but no studies have been conducted on the left snuffbox approach.
The purpose of this study was to compare the radiation doses of the two interventional radiologists by randomly assigning coronary angiography to the left snuffbox approach and right conventional radial approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized either conventional right radial approach or left distal radial approach.
| Arm | Type | Receives |
|---|---|---|
| Right conventional radial approach | Placebo comparator | Procedure: artery puncture and coronary angiographyAfter local anesthesia on right wrist area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). |
| Left distal radial approach | Active comparator | Procedure: artery puncture and coronary angiographyAfter local anesthesia on left anatomical snuffbox area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are a palpable right radial artery and left distal radial artery
- The decision to participate voluntarily in this study and the written consent of the patient
Key exclusion criteria (8 listed)
- Patients who are not palpable right radial artery and left distal radial artery
- Patients who have arteriovenous fistula
- Patients presenting with acute myocardial infarction
- Patients who need to perform coronary angiography via femoral approach, such as shock state
- Patients who have atrioventricular block on the electrocardiogram
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 |
|---|---|---|
| artery puncture and coronary angiographyWe will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea). | Procedure or surgery | Left distal radial approach, Right conventional radial approach |
Primary outcome
Radiation dose of the operator (µSv)
Time frame: Through procedure completion, up to 6 hours
Radiation dose (µSv) of the operator's head, hand, and body will be compared between right conventional radial artery approach and left snuffbox approach group.
6 secondary outcomes
Fluoroscopy time for coronary angiography (second)
Time frame: Through procedure completion, up to 6 hours
Dose-area product (mGy*cm2)
Time frame: Through procedure completion, up to 6 hours
Success rate of radial puncture (%)
Time frame: Through procedure completion, up to 6 hours
Cannulation time (second)
Time frame: Through procedure completion, up to 6 hours
Hemostasis duration (minute)
Time frame: During hospitalization, up to 1 month
Puncture site complication after hemostasis
Time frame: During hospitalization, up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Yongcheol Kim, MD study director
Department of Cardiology, Chonnam National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing artery puncture and coronary angiography in people with Radiation Exposure and Vascular Access Complication, run by Chonnam National University Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongcheol Kim, MD (+82-10-5808-4029, Dr.YongcheolKim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose of the operator (µSv) (time frame: Through procedure completion, up to 6 hours). 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 18 Jul 2019.