NCT07009678Completed
Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
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
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 12 May 2025
- Start date
- 1 Mar 2023
- Primary completion date
- 12 May 2025
- Lead sponsor
- St. John's Hospital
- Diseases
- Stroke
- NCT number
- NCT07009678
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 1 Mar 2023 to the primary completion date, 12 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 4.2. Inclusion Criteria
- The subject is / has:
- Age ≥18 at the time of informed consent signature.
- Capable of complying with protocol requirements, including follow-up.
- A Consent Form signed by Subject or legal representative.
- Subjects have a history of concern for right to left shunt, such as a paradoxical embolus as source of a cryptogenic CVA requiring transthoracic echocardiography with agitated saline injection (bubble study)
- No evidence of right to left shunt on injection of upper extremity using transthoracic echocardiography within the previous 24 months
- If taking warfarin, patient is eligible if clinically able to hold warfarin for 3 days prior to procedure.
- 4.3. Exclusion Criteria
- The subject is / has:
- Enrolled in another drug or medical device study within 30 days of study enrollment.
- Absence or size \< 2mm diameter of both greater saphenous veins
- Depth of the greater saphenous vein is \> 3cm from the skin surface
- Presence of deep vein thrombosis in either greater saphenous veins
- Platelet count less than 50,000
- International Normalized Ratio (INR) \> 3 or liver failure within the last 6 months,
- Taking oral anticoagulant (DOAC) within 24 hours
- Taking high dose anticoagulation with heparin or low molecular weight heparin within 12 hours
- Absence of adequate windows for echocardiographic imaging to detect shunt
- Subject is unable to sign consent or considered a part of a vulnerable population: children/minors or age \< 18 years, pregnant women, prisoners, terminally ill, comatose, intellectually challenged individuals who are assigned a guardian, institutionalized individuals, visual or hearing impaired without therapy to overcome the impairment, refugees.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. John's hospital Coordinator of this site? Confirm its status | Maple Grove | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.