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出境医 / 临床实验 / Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach (DOSE)
Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach (DOSE)
Study Description
Brief Summary:
Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Radiation Exposure Vascular Access Complication Radial Artery Injury | Procedure: artery puncture and coronary angiography | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients will be randomized either conventional right radial approach or left distal radial approach. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial |
| Estimated Study Start Date : | August 2019 |
| Estimated Primary Completion Date : | August 2019 |
| Estimated Study Completion Date : | December 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Right conventional radial approach
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).
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Procedure: artery puncture and coronary angiography
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).
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Active Comparator: Left distal radial approach
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).
|
Procedure: artery puncture and coronary angiography
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).
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Fluoroscopy time for coronary angiography (second) [ Time Frame: Through procedure completion, up to 6 hours ]Fluoroscopy time (second) will be compared between two groups during coronary angiography.
- Dose-area product (mGy*cm2) [ Time Frame: Through procedure completion, up to 6 hours ]Dose-area product (DAP) (mGy*cm2) will be compared between two groups during coronary angiography.
- Success rate of radial puncture (%) [ Time Frame: Through procedure completion, up to 6 hours ]Successful introduction of sheath (%)
- Cannulation time (second) [ Time Frame: Through procedure completion, up to 6 hours ]Time from local anesthesia to sheath cannulation (second)
- Hemostasis duration (minute) [ Time Frame: During hospitalization, up to 1 month ]Hemostasis (minute) is obtained by compressive bandage with ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea)
- Puncture site complication after hemostasis [ Time Frame: During hospitalization, up to 1 month ]Evaluation of puncture-site bleeding complication using EASY criteria
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Yongcheol Kim, MD | +82-10-5808-4029 | Dr.YongcheolKim@gmail.com |
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
| Study Director: | Yongcheol Kim, MD | Department of Cardiology, Chonnam National University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 16, 2019 | ||||
| First Posted Date ICMJE | July 18, 2019 | ||||
| Last Update Posted Date | July 18, 2019 | ||||
| Estimated Study Start Date ICMJE | August 2019 | ||||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach | ||||
| Official Title ICMJE | Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial | ||||
| Brief Summary | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients will be randomized either conventional right radial approach or left distal radial approach. Masking: None (Open Label)Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: artery puncture and coronary angiography
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).
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2020 | ||||
| Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04023838 | ||||
| Other Study ID Numbers ICMJE | DOSE | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Myung Ho Jeong, Chonnam National University Hospital | ||||
| Study Sponsor ICMJE | Chonnam National University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Chonnam National University Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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