NCT04869150

Brief Summary

Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

3.1 years

First QC Date

April 28, 2021

Last Update Submit

May 4, 2021

Conditions

Keywords

myocardial bridgeradial access coronary angiography

Outcome Measures

Primary Outcomes (1)

  • Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography?

    the incidence of MB able to be detected on RACA was much higher than reported in previous CCA studies.

    1 month

Study Arms (2)

those with myocardial bridges

Procedure: radial access coronary angiography

those without myocardial bridges

Interventions

The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter

those with myocardial bridges

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective evaluation was made of the coronary angiographies of 2600 consecutive patients who underwent radial access coronary angiography between January 2018 and February 2020

You may qualify if:

  • Undergoing radial access coronary angiography
  • Have myocardial bridge

You may not qualify if:

  • A history of coronary artery bypass grafting (CABG)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial Bridging

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

February 8, 2018

Primary Completion

March 29, 2021

Study Completion

March 29, 2021

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations