Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04343209
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2020-04-07
Brief Title:
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD Ammonia MAP
Sponsor:
Ionetix Corporation
Organization:
Ionetix Corporation
Study Overview
Official Title:
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease Ammonia MAP
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography PET using a specific radioactive drug called Ammonia N-13 Ammonia referred to simply as an Ammonia PET scan which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart The scanner used in this study may be a stand-alone PET scanner or a PETCT scanner which combines the PET scanner and a Computed Tomography CT scanner into a single device Unless otherwise stated in this consent form the term PET will be used to refer to both stand-alone PET and PETCT scanners While physicians have used the Ammonia PET test for many years to visualize image the blood flow into the heart muscle perfusion it is now possible to also measure the flow of blood into the heart muscle Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle Therefore this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference
Detailed Description:
This is a prospective multicenter database that will be populated by sites utilizing N-13 Ammonia and sponsored by Ionetix Each site with access to N-13 produced under an investigational new drug IND application will be eligible to participate Once the site is activated the site will enroll patients into the database that are scheduled for clinically indicated PET-MPI with N-13 as determined by their treating physicians PET-MPI perfusion MBF percent ischemia pharmacologic stress agent and gated left ventricular ejection fractionfunction values will be collected when available in an anonymous fashion and uploaded into the database All patient health identifiers PHI will be removed prior to upload No procedures additional to those clinically indicated will be performed for the purposes of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None