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Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL)

Primary Purpose

Myocardial Infarction, Coronary Artery Disease, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fluoroscopic + Ultrasound Guidance
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluoroscopic + Ultrasound Guidance

Fluoroscopic Guidance Alone

Arm Description

Outcomes

Primary Outcome Measures

Incidence of major vascular complications
Femoral artery pseudoaneurysm, AV fistula, retroperitoneal bleed, large hematoma (>5 cm), ischemic limb requiring intervention or surgery, or major bleed based on BARC II, III, or V criteria

Secondary Outcome Measures

Full Information

First Posted
May 15, 2018
Last Updated
August 9, 2022
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03537118
Brief Title
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures
Acronym
UNIVERSAL
Official Title
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease, Myocardial Ischemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
621 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopic + Ultrasound Guidance
Arm Type
Experimental
Arm Title
Fluoroscopic Guidance Alone
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopic + Ultrasound Guidance
Intervention Description
Fluoroscopic Guidance Alone
Primary Outcome Measure Information:
Title
Incidence of major vascular complications
Description
Femoral artery pseudoaneurysm, AV fistula, retroperitoneal bleed, large hematoma (>5 cm), ischemic limb requiring intervention or surgery, or major bleed based on BARC II, III, or V criteria
Time Frame
up to 30 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned. Planned femoral access Exclusion Criteria: Age ≤ 18 years STEMI Absence of palpable femoral pulse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjit S Jolly, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tej Sheth, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Winter, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36116089
Citation
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.
Results Reference
derived
PubMed Identifier
34637140
Citation
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.
Results Reference
derived

Learn more about this trial

Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

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