Rapid Clamp Release Post Trans-radial Cardiac Catheterization

NCT ID: NCT03645837

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-06-01

Brief Summary

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The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.

Detailed Description

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This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.

Conditions

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Cardiac Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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10 minutes

Compression clamp release start after 10 minutes

Group Type EXPERIMENTAL

Compression clamp release

Intervention Type OTHER

Standard compression clamp is used and will be released at different times according to randomization

20 minutes

Compression clamp release start after 20 minutes

Group Type EXPERIMENTAL

Compression clamp release

Intervention Type OTHER

Standard compression clamp is used and will be released at different times according to randomization

30 minutes

Compression clamp release start after 30 minutes

Group Type ACTIVE_COMPARATOR

Compression clamp release

Intervention Type OTHER

Standard compression clamp is used and will be released at different times according to randomization

Interventions

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Compression clamp release

Standard compression clamp is used and will be released at different times according to randomization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnostic catheterization
2. 5 F slender sheath
3. Normal ulno-palmar circulation

Exclusion Criteria

1. Abnormal ulno-palmar circulation type D
2. Ad hoc percutaneous coronary intervention
3. Heparin or other anticoagulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahar Lavi, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sceinces Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.

Reference Type BACKGROUND
PMID: 28159821 (View on PubMed)

Other Identifiers

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112619

Identifier Type: -

Identifier Source: org_study_id

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