Snuff-box Deep Palmar Arch Artery Versus Radial Angiography

• Sponsor: Hamidreza Mahboobi (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03373565
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 33.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Procedure: Radial; Procedure: Palmar	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Dec 20, 2017
• Anticipated Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radial Coronary angiography using radial approach	Procedure: Radial; Coronary angiography using radial approach
Experimental: palmar Coronary angiography using palmar approach	Procedure: Palmar; Coronary angiography using radial approach

Outcome Measures

Primary Outcome Measures

1. Thrombosis [1 months]

   Thrombosis at the site of angiography using ultrasonography

Secondary Outcome Measures

1. Infection [1 months]

   Number of patients with infection at the site of angiography in physical examnination

2. Pain [1 months]

   Number of patients with pain at the site of angiography using questionnaire

3. Numbness [1 months]

   Number of patients with numbness at the site of angiography using questionnaire

4. Loss of movement [1 months]

   Number of patients with loss of movement at the site of angiography in physical examination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hormozgan University of Medical Sciences	Bandar Abbas	Hormozgan	Iran, Islamic Republic of

Sponsors and Collaborators

• Hamidreza Mahboobi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamidreza Mahboobi, Principle Investigator, Hormozgan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03373565
• Other Study ID Numbers: HUMS.REC.1396.82
• First Posted: Dec 14, 2017
• Last Update Posted: Dec 14, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease

Study Results

No Results Posted as of Dec 14, 2017