NCT03373565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

November 18, 2017

Last Update Submit

December 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thrombosis

    Thrombosis at the site of angiography using ultrasonography

    1 months

Secondary Outcomes (4)

  • Infection

    1 months

  • Pain

    1 months

  • Numbness

    1 months

  • Loss of movement

    1 months

Study Arms (2)

Radial

ACTIVE COMPARATOR

Coronary angiography using radial approach

Procedure: Radial

palmar

EXPERIMENTAL

Coronary angiography using palmar approach

Procedure: Palmar

Interventions

RadialPROCEDURE

Coronary angiography using radial approach

Radial
PalmarPROCEDURE

Coronary angiography using radial approach

palmar

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication of coronary artery angiography confirmed by a cardiologist
  • Accepting to sign the written informed consent

You may not qualify if:

  • No follow up visit after one-month period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, Iran

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Hosein Farshidi, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 18, 2017

First Posted

December 14, 2017

Study Start

July 1, 2017

Primary Completion

December 20, 2017

Study Completion

December 30, 2017

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations