RECRUITING

RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This a Phase 3, prospective, open-label, multicenter study of \[15-O\]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of \[15-O\]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the \[15-O\]-H2O scan.

Official Title

A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)

Quick Facts

Study Start:2022-05-08
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05134012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female participants ≥18 years;
  2. 2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
  3. 3. Participants who fall into any one of the following categories:
  4. 1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
  5. 2. Had an ICA with no intervention. However, if any stenosis \>40% but ≤70% was observed, an FFR or iFR assessment was performed.
  6. 3. Had a CCTA with normal coronaries or minimal CAD (no stenosis \>25%).
  7. 4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative; these participants must be practicing appropriate birth control from time of the screening visit until the end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.
  8. 5. Male will need to use contraceptive methods until end of the follow-up period.
  9. 6. Participants are able to comply with all study procedures as described in the protocol.
  1. 1. Participants are unable to undergo (even partially) any of the imaging procedures;
  2. 2. Participants with a known history of cardiac disease including:
  3. 1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
  4. 2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
  5. 3. known left ventricular dysfunction
  6. 4. moderate or severe aortic or mitral stenosis or regurgitation
  7. 3. Participants in whom adenosine stress testing is contraindicated, including but not limited to:
  8. 1. Participants with severe COPD or chronic asthma.
  9. 2. Participants with second- or third-degree atrioventricular block without a pacemaker.
  10. 4. Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
  11. 5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy or on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil),and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug.
  12. 6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
  13. 7. Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (patients in observational studies with approved agents and participants known to be on placebo may be enrolled).
  14. 8. Participants who have previously participated in this study.
  15. 9. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)

Contacts and Locations

Study Contact

Sandra Miran (Europe)
CONTACT
+45 22 16 74 22
sandra@medtrace.dk
Emily Scott (North America)
CONTACT
+1 6125233582
scott@medtrace.dk

Principal Investigator

Nicholas Borys, MD
STUDY_DIRECTOR
MedTrace Pharma A/S
Marcelo DiCarli, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52242
United States
BAMF Healthcare
Grand Rapids, Michigan, 49503
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: MedTrace Pharma A/S

  • Nicholas Borys, MD, STUDY_DIRECTOR, MedTrace Pharma A/S
  • Marcelo DiCarli, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-08
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-05-08
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Myocardial Blood Flow (MBF)
  • Myocardial Perfusion Imaging (MPI)
  • RAPID-WATER-FLOW
  • Positron Emission Tomography (PET)
  • Oxygen-15
  • Coronary Artery Disease (CAD)

Additional Relevant MeSH Terms

  • Coronary Artery Disease