NCT07009678: LOCATE

Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography

Completed NA Last updated 6 June 2025

What this trial tests

NA trial testing intravenous access in greater saphenous vein compared to upper extremity site. in Patent Foramen Ovale in 21 participants. Completed in 12 May 2025.

Timeline

1 March 2023

Primary endpoint
12 May 2025

12 May 2025

Quick facts

Lead sponsor	St. John's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	21
Start date	1 March 2023
Primary completion	12 May 2025
Estimated completion	12 May 2025
Sites	1 location across United States

Drugs / interventions tested

• intravenous access in greater saphenous vein compared to upper extremity site.

Conditions studied

• Patent Foramen Ovale — all drugs for Patent Foramen Ovale →
• Cryptogenic Stroke — all drugs for Cryptogenic Stroke →
• Embolic Infarction — all drugs for Embolic Infarction →

Sponsor

St. John's Hospital

Who can join

18 and older, any sex, with Patent Foramen Ovale or Cryptogenic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.

Primary Investigator Carmelo Panetta, MD University of Minnesota Physicians, St. John's Hospital 1600 St. Johns Blvd, suite 200, Maplewood, MN 55109

Study Design Prospective study of the safety and efficacy upper versus lower extremity injection agitated saline (bubble study) to identify patent foramen ovale (PFO) with echocardiography

Study Objective PFO are not identified in up to one quarter of subjects who have upper arm injection compared to femoral vein injection. We propose use of the PICC line nurses to obtain access in the greater saphenous vein in the lower leg and compare to the upper extremity injection in those subjects with concern for paradoxical embolus but previously PFO was not identified with an upper arm injection.

Study Endpoint Study the safety and efficacy of lower versus upper extremity injection agitated saline (bubble study) for identifying PFO

Subject Population Subjects with history of cryptogenic stroke or arterial embolus of unknown source with negative upper extremity injection agitate saline (bubble study) to identify a PFO.

Number of Sites Three sites to enroll subjects: St. John's/Woodwinds Hospital, University of Minnesota Medical Center and Southdale Hospital. One site to perform procedure at St John's hospital

Expected Time to Complete Enrollment 8-12 months

Schedule of Events Screening and consent of subjects who with negative bubble study for PFO to have upper and lower extremity bubble study, one week follow up and review echocardiography by two cardiologists.

Additional Information Data safety monitoring board will oversee the results every quarter Sample size 20 subjects were consented and enrolled is supported by this grant from GORE Medical.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.