UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055256 |
|---|---|
| Receipt number | R000060593 |
| Scientific Title | Patient satisfaction, pain, and complication by site of puncture among patients undergoing cardiac catheterization |
| Date of disclosure of the study information | 2024/08/16 |
| Last modified on | 2024/08/16 13:23:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Patient satisfaction, pain, and complication by site of puncture among patients undergoing cardiac catheterization
Acronym
Patient satisfaction, pain, and complication by site of puncture among patients undergoing cardiac catheterization
Scientific Title
Patient satisfaction, pain, and complication by site of puncture among patients undergoing cardiac catheterization
Scientific Title:Acronym
Patient satisfaction, pain, and complication by site of puncture among patients undergoing cardiac catheterization
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ischemic heart disease is one of the major causes of death in developed countries, and cardiac catheterization are performed worldwide. In the past, femoral artery puncture was the mainstay of catheterization, but radial artery puncture is now the mainstay of catheterization for less invasive procedures and to reduce bleeding complications. In addition, a new approach using the distal radial artery has emerged. In general, the radial artery, brachial artery, femoral artery, and distal radial artery are the four most common puncture sites, but the differences in compression time, hemostatic success rate, bleeding complications, pain, and numbness, and patient satisfaction are not yet clear.
Therefore, based on prospectively obtained patient questionnaires, we will investigate pain, satisfaction, and complication rates by puncture site.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain, numbness, patient satisfaction, and bleeding complications
Key secondary outcomes
Puncture time, hemostasis time, surgeon changeover
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Patient with radial artery puncture
Interventions/Control_2
Patient with distal radial artery puncture
Interventions/Control_3
Patient with brachial artery puncture
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing coronary angiography or percutaneous coronary angioplasty
Key exclusion criteria
Patients who did not respond to the questionnaire at the time of catheterization
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Domei |
Organization
Kokura memorial hospital
Division name
Cardiovascular Medicine
Zip code
8020001
Address
Asano 3-2-1, Kokura-kitaku, Kitakyusyu, Fukuoka, Japan
TEL
81935112000
dotake310@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura memorial hospital
Division name
Cardiovascular Medicine
Zip code
8020001
Address
Asano 3-2-1, Kokura-kitaku, Kitakyusyu, Fukuoka, Japan
TEL
81935112000
Homepage URL
kanesannsann@yahoo.co.jp
Sponsor or person
Institute
Kokura memorial hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center,Kokura Memorial Hospital
Address
3-2-1 Asano, Kokura kita-ku,Kitakyushu-city, Fukuoka, 802-8555, Japan
Tel
81-93-511-2000
crc@kokurakinen.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1272
Results
While DRA was more difficult to perform, patients in the DRA group experienced less discomfort and had preserved ADLs during compression hemostasis and had higher overall satisfaction. This study found that increasing the puncture success rate required an adequate training period for physicians, left-sided access, and a distal radial artery diameter of at least 2 mm.
Results date posted
| 2024 | Year | 08 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data collection took time.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060593
