Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

NCT ID: NCT03537118

Last Updated: 2022-08-12

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

621 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2022-07-15

Brief Summary

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A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.

Detailed Description

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Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.

Conditions

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Myocardial Infarction Coronary Artery Disease Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluoroscopic + Ultrasound Guidance

Group Type EXPERIMENTAL

Fluoroscopic + Ultrasound Guidance

Intervention Type PROCEDURE

Fluoroscopic Guidance Alone

Fluoroscopic Guidance Alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fluoroscopic + Ultrasound Guidance

Fluoroscopic Guidance Alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
2. Planned femoral access

Exclusion Criteria

1. Age ≤ 18 years
2. STEMI
3. Absence of palpable femoral pulse
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjit S Jolly, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Tej Sheth, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Jose Winter, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Strauss SA, Ma GW, Seo C, Siracuse JJ, Madassery S, Truesdell AG, Pereira K, Korngold EC, Kayssi A. Ultrasound-guided versus anatomic landmark-guided percutaneous femoral artery access. Cochrane Database Syst Rev. 2025 Mar 28;3(3):CD014594. doi: 10.1002/14651858.CD014594.pub2.

Reference Type DERIVED
PMID: 40152297 (View on PubMed)

Jolly SS, AlRashidi S, d'Entremont MA, Alansari O, Brochu B, Heenan L, Skuriat E, Tyrwhitt J, Raco M, Tsang M, Valettas N, Velianou JL, Sheth T, Sibbald M, Mehta SR, Pinilla-Echeverri N, Schwalm JD, Natarajan MK, Kelly A, Akl E, Tawadros S, Camargo M, Faidi W, Bauer J, Moxham R, Nkurunziza J, Dutra G, Winter J. Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 1;7(11):1110-1118. doi: 10.1001/jamacardio.2022.3399.

Reference Type DERIVED
PMID: 36116089 (View on PubMed)

Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

Reference Type DERIVED
PMID: 34637140 (View on PubMed)

Other Identifiers

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UNIVERSAL.2018

Identifier Type: -

Identifier Source: org_study_id

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