Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
Primary Purpose
Ischemic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Radial
Palmar
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- indication of coronary artery angiography confirmed by a cardiologist
- Accepting to sign the written informed consent
Exclusion Criteria:
- No follow up visit after one-month period
Sites / Locations
- Hormozgan University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radial
palmar
Arm Description
Coronary angiography using radial approach
Coronary angiography using palmar approach
Outcomes
Primary Outcome Measures
Thrombosis
Thrombosis at the site of angiography using ultrasonography
Secondary Outcome Measures
Infection
Number of patients with infection at the site of angiography in physical examnination
Pain
Number of patients with pain at the site of angiography using questionnaire
Numbness
Number of patients with numbness at the site of angiography using questionnaire
Loss of movement
Number of patients with loss of movement at the site of angiography in physical examination
Full Information
NCT ID
NCT03373565
First Posted
November 18, 2017
Last Updated
December 13, 2017
Sponsor
Hamidreza Mahboobi
1. Study Identification
Unique Protocol Identification Number
NCT03373565
Brief Title
Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
Official Title
Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hamidreza Mahboobi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions.
New angiographic methods are associated with variable complications. Death, myocardial infarction, and stroke are among major angiography complications. In addition, some local complications including bleeding at the site of insertion, infection, arteriovenous fistula, pseudoaneurysm, and thrombosis is reported after angiography.
Radial and femoral methods are common angiographic methods. Its shown that radial method is associated with less complications and patients need shorter duration of hospitalization.
Radial artery thrombosis is common complication of radial angiography. However, the prevalence is between 5 to 19 percent but often it is not clinically important. Risk of ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals. In patients with incomplete palmar arch this is important and may cause ischemia.
The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep palmar arch artery and radial artery in patients attending angiography center of Shahid Mohammadi hospital in Bandar Abbas in 2017.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radial
Arm Type
Active Comparator
Arm Description
Coronary angiography using radial approach
Arm Title
palmar
Arm Type
Experimental
Arm Description
Coronary angiography using palmar approach
Intervention Type
Procedure
Intervention Name(s)
Radial
Intervention Description
Coronary angiography using radial approach
Intervention Type
Procedure
Intervention Name(s)
Palmar
Intervention Description
Coronary angiography using radial approach
Primary Outcome Measure Information:
Title
Thrombosis
Description
Thrombosis at the site of angiography using ultrasonography
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Infection
Description
Number of patients with infection at the site of angiography in physical examnination
Time Frame
1 months
Title
Pain
Description
Number of patients with pain at the site of angiography using questionnaire
Time Frame
1 months
Title
Numbness
Description
Number of patients with numbness at the site of angiography using questionnaire
Time Frame
1 months
Title
Loss of movement
Description
Number of patients with loss of movement at the site of angiography in physical examination
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication of coronary artery angiography confirmed by a cardiologist
Accepting to sign the written informed consent
Exclusion Criteria:
No follow up visit after one-month period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hosein Farshidi, M.D
Phone
09173613517
Ext
+98
Email
hfarshidi6@gmail.com
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hosein Farshidi, M.D
Phone
9173613517
Ext
+98
Email
hfarshidi6@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
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