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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134012
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
MedTrace Pharma A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study. 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).
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : May 8, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
All participants with suspected CAD 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).
Drug: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
[15-O]-H2O injection is a novel PET imaging agent labeled with the radioisotope [15-O] administered as an intravenous (IV) injection. Participants will receive [15-O]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of [15-O]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress.




Primary Outcome Measures :
  1. Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR or CCTA. [ Time Frame: 30 days ]

    Sensitivity and specificity are defined as follows:

    • True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard
    • True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard
    • False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard
    • False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard
    • Sensitivity: TP/(TP + FN)
    • Specificity: TN/(TN + FP)


Secondary Outcome Measures :
  1. Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease). [ Time Frame: 30 days ]

    Sensitivity and specificity are defined as follows:

    • True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard
    • True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard
    • False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard
    • False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard
    • Sensitivity: TP/(TP + FN)
    • Specificity: TN/(TN + FP)
    • Accuracy: (TN + TP)/(TN + TP + FN + FP)

  2. Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse. [ Time Frame: 30 days ]

    Other Safety measures including the following will be summarized descriptively:

    1. ECG (ventricular heart rate, PR interval, QRS duration, QT interval, QTc interval)
    2. Vital Signs
    3. Concomitant Medications
    4. Protocol Deviations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female participants ≥18 years;
  2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
  3. Participants who fall into any one of the following categories:

    1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
    2. Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR assessment was performed.
    3. Had a CCTA with normal coronaries or minimal CAD (no stenosis >20%).

    The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three tests.

  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.
  5. Male will need to use contraceptive methods until end of the follow-up period.
  6. Participants are able to comply with all study procedures as described in the protocol.

Exclusion Criteria:

  1. Participants are unable to undergo (even partially) any of the imaging procedures;
  2. Participants with a known history of cardiac disease including:

    1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
    2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
    3. known left ventricular dysfunction
  3. Participants in whom adenosine stress testing is contraindicated, including but not limited to:

    1. Participants with severe COPD or chronic asthma.
    2. Participants with second- or third-degree atrioventricular block without a pacemaker.
  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).
  5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug.
  6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
  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).
  8. Participants who have previously participated in this study.
  9. Participants with a close affiliation with the investigational site, defined as a close relative to the Investigator, or a dependent person such as an employee, student or intern at the investigational site.
  10. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or enrollment and 15O-H2O PET MPI (pathway 2 and 3)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05134012


Contacts
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Contact: Taylor A Williams 16178024048 ext 162 twilliams@ccstrials.com
Contact: Michael DiBattista mdibattista@ccstrials.com

Locations
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United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Parren S McNeely, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Geoffrey B Johnson, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Thomas Schindler, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Prem Soman, MD         
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Orhan Oz, MD         
Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark
Contact: Professor, Department of Nuclear Medicine & PET-Centre         
Sponsors and Collaborators
MedTrace Pharma A/S
Investigators
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Study Director: Emily Vandenbroucke, PhD MedTrace Pharma A/S
Principal Investigator: Marcelo DiCarli, MD Brigham and Women's Hospital
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Responsible Party: MedTrace Pharma A/S
ClinicalTrials.gov Identifier: NCT05134012    
Other Study ID Numbers: MedTrace-002
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MedTrace Pharma A/S:
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:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases