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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06392347
Other study ID # 853628
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2023
Est. completion date July 2028

Study information

Verified date May 2024
Source University of Pennsylvania
Contact Jae Song, MD
Phone 215-349-8023
Email jae.song@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare and evaluate a faster MR image that has been optimized to look at participants blood vessel walls.


Description:

The purpose of this study is to compare and evaluate a faster MR image that has been optimized to look at participants blood vessel walls. This faster MR image technique will image participants blood vessel walls in a shorter period of time and will be compared to the routine MR images that is typically used to image participants blood vessel walls. The purpose of testing these faster images is to compare the image quality with longer conventional images. The goal is to ensure the investigators maintain high image quality over a shorter period of time. These faster images over a shorter period of time have the advantage of fewer motion-related artifacts. The hypothesis of this research study is that the compressed sensing (fast acquisition technique) based acquisitions will considerably reduce the scan time and will maintain the diagnostic image quality necessary for the assessment of participants blood vessel walls. Thus, the information gained from this study will help us to determine the efficacy of the accelerated protocols for vessel wall imaging.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date July 2028
Est. primary completion date June 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. Patients 18 years of age and scheduled to undergo clinical vessel wall MR imaging exams as part of their standard of care. Exclusion Criteria: 1. Any person under the age of 18 2. Presence of artifact-producing intracranial devices (aneurysm clips/coils, ventricular drains, craniectomy mesh, etc.) 3. Any person with contraindications to MRI (medical instability, non-MRI compatible implanted devices, retained metallic foreign bodies, claustrophobia) 4. Large space-occupying lesions (50 mL) or substantial mass effect (herniation, 5mm midline shift) on preceding brain imaging, 5. Imminently life-threatening co-morbid conditions 6. A history of premorbid disabling neurological or psychiatric disease, current substance abuse or remote substance abuse with permanent organic sequelae 7. Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pennsylvania Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optimizing scan efficiency of T1-weighted (T1w) imaging for vessel wall imaging protocols The primary outcome of the study will be the raters study where qualitative imaging scores will be provided by experienced radiologists using a four-point scale. 24 months
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