Recruiting
Early Phase 1

MRI Methods

Sponsor:

University of Utah

Code:

NCT04600115

Conditions

MRI Scans

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Adenosine

Regadenoson

O-15 labeled radioactive water

MRI

PET Imaging

Study Details

Brief summary:

This study's main specific aims are;

1. To develop robust acquisition and reconstruction methods specifically for the study of microvascular cardiac remodeling with MRI which will include very innovative quantitative perfusion methods, as well as fibrosis quantification, longitudinal strain, and phase contrast imaging for flow.
2. Test the new methods for identifying the clinical task of characterizing HFpEF.

Conditions

MRI Scans

Study ID

NCT04600115

Start date

Mar 3, 2017

Status verified date

Jul, 2026

Completion date

Mar 3, 2027

Anticipated

Primary completion date

Mar 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All participants will be over the age of 18 and able to provide consent

  • Group A (volunteers, with or without cardiac disease): Volunteers will be available for at least one study visit
  • Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF and be safe to be imaged with MRI

Exclusion Criteria:

  • minors
  • Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.
  • Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).
  • Patients with contraindication to MRI (metal implants, or certain types of heart valves),
  • pregnant patients, , mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).
  • Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents.
  • This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.
  • Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress MRI cohorts.
  • All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each MRI
  • Subjects with a known contraindication to Adenosine and/or Regadenoson will only be enrolled in scans where no stress agent will be administered

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: MRI vs.PET with/without Cardiac disease

Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging

Interventions

Adenosine

Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion

Regadenoson

0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.

O-15 labeled radioactive water

O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging

MRI

Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

PET Imaging

Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day

Primary outcome measure

  • Myocardial perfusion measured with MRI [ Time Frame: Time in the scanner to be 60-90 minutes. ]

Central Contacts and Locations

Central contacts

Olivia Pratt, BS

801-585-6142u0447662@umail.utah.edu

Collin Arsenault, BS.

801-587-8638collin.arsenault@hsc.utah.edu

Locations

university of Utah, Radiology Research

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Olivia Pratt, BS

801-585-6142u0447662@umail.utah.edu

Collin Arsenault, BS

801-587-8638Collin.arsenault@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-07-07.