UNIVERSAL: Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

• Sponsor: Population Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03537118
• Collaborator: (none)
• Enrollment: 621
• Location: 1
• Arms: 2
• Actual Duration (Months): 48.8
• Patients Per Site Per Month: 12.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia	Procedure: Fluoroscopic + Ultrasound Guidance	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 621 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
• Actual Study Start Date: Jun 20, 2018
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluoroscopic + Ultrasound Guidance	Procedure: Fluoroscopic + Ultrasound Guidance; Fluoroscopic Guidance Alone
No Intervention: Fluoroscopic Guidance Alone

Outcome Measures

Primary Outcome Measures

1. Incidence of major vascular complications [up to 30 days post-procedure]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences	Hamilton	Ontario	Canada	L8L2X2

Sponsors and Collaborators

• Population Health Research Institute

Investigators

• Principal Investigator: Sanjit S Jolly, MD, Population Health Research Institute
• Principal Investigator: Tej Sheth, MD, Population Health Research Institute
• Principal Investigator: Jose Winter, MD, Population Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Population Health Research Institute
• ClinicalTrials.gov Identifier: NCT03537118
• Other Study ID Numbers: UNIVERSAL.2018
• First Posted: May 25, 2018
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Infarction; Ischemia

Study Results

No Results Posted as of Aug 12, 2022