Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)

NCT ID: NCT04343209

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2024-08-16

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 PET/CT 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 PET/CT 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 fraction/function 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.

Conditions

Myocardial Ischemia; Coronary Disease; Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals with confirmed or suspected cardiovascular disease

Individuals in this group will undergo myocardial perfusion imaging, utilizing Ammonia N-13 PET imaging agent. Each individual will receive two intravenous injections of Ammonia N-13 in accordance with site imaging protocol.

Myocardial Perfusion Imaging Study

Intervention Type: DIAGNOSTIC_TEST

Evaluation of myocardial perfusion via PET imaging agent

AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]

Intervention Type: DRUG

Cardiac PET imaging agent

Interventions

Myocardial Perfusion Imaging Study

Evaluation of myocardial perfusion via PET imaging agent

Intervention Type: DIAGNOSTIC_TEST

AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]

Cardiac PET imaging agent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Adults ≥18 able to give informed consent.

Clinical indication for PET-MPI as determined by the subject's treating physician

Exclusion Criteria

Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically.

Inability or unwilling to give informed consent

Pregnant subjects

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ionetix Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Oliverio

Role: STUDY_DIRECTOR

Ionetix Corporation

Locations

Doral Imaging Institute, LLC dba CIRA

Miami, Florida, United States

Doral Imaging Institute, LLC DBA CIRA Miami Beach

Miami Beach, Florida, United States

Adler Institute for Advanced Imaging

Jenkintown, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Molecular Imaging Technologies

El Paso, Texas, United States

Countries

United States

References

Araujo LI, Lammertsma AA, Rhodes CG, McFalls EO, Iida H, Rechavia E, Galassi A, De Silva R, Jones T, Maseri A. Noninvasive quantification of regional myocardial blood flow in coronary artery disease with oxygen-15-labeled carbon dioxide inhalation and positron emission tomography. Circulation. 1991 Mar;83(3):875-85. doi: 10.1161/01.cir.83.3.875.

Reference Type: RESULT

PMID: 1900224 (View on PubMed)

Bergmann SR, Herrero P, Markham J, Weinheimer CJ, Walsh MN. Noninvasive quantitation of myocardial blood flow in human subjects with oxygen-15-labeled water and positron emission tomography. J Am Coll Cardiol. 1989 Sep;14(3):639-52. doi: 10.1016/0735-1097(89)90105-8.

Reference Type: RESULT

PMID: 2788669 (View on PubMed)

Sdringola S, Johnson NP, Kirkeeide RL, Cid E, Gould KL. Impact of unexpected factors on quantitative myocardial perfusion and coronary flow reserve in young, asymptomatic volunteers. JACC Cardiovasc Imaging. 2011 Apr;4(4):402-12. doi: 10.1016/j.jcmg.2011.02.008.

Reference Type: RESULT

PMID: 21492816 (View on PubMed)

Merlet P, Mazoyer B, Hittinger L, Valette H, Saal JP, Bendriem B, Crozatier B, Castaigne A, Syrota A, Rande JL. Assessment of coronary reserve in man: comparison between positron emission tomography with oxygen-15-labeled water and intracoronary Doppler technique. J Nucl Med. 1993 Nov;34(11):1899-904.

Reference Type: RESULT

PMID: 8229231 (View on PubMed)

Kern MJ, Bach RG, Mechem CJ, Caracciolo EA, Aguirre FV, Miller LW, Donohue TJ. Variations in normal coronary vasodilatory reserve stratified by artery, gender, heart transplantation and coronary artery disease. J Am Coll Cardiol. 1996 Nov 1;28(5):1154-60. doi: 10.1016/S0735-1097(96)00327-0.

Reference Type: RESULT

PMID: 8890809 (View on PubMed)

Gewirtz H, Fischman AJ, Abraham S, Gilson M, Strauss HW, Alpert NM. Positron emission tomographic measurements of absolute regional myocardial blood flow permits identification of nonviable myocardium in patients with chronic myocardial infarction. J Am Coll Cardiol. 1994 Mar 15;23(4):851-9. doi: 10.1016/0735-1097(94)90629-7.

Reference Type: RESULT

PMID: 8106689 (View on PubMed)

Rivas F, Cobb FR, Bache RJ, Greenfield JC Jr. Relationship between blood flow to ischemic regions and extent of myocardial infarction. Serial measurement of blood flow to ischemic regions in dogs. Circ Res. 1976 May;38(5):439-47. doi: 10.1161/01.res.38.5.439.

Reference Type: RESULT

PMID: 1269083 (View on PubMed)

Renaud JM, Yip K, Guimond J, Trottier M, Pibarot P, Turcotte E, Maguire C, Lalonde L, Gulenchyn K, Farncombe T, Wisenberg G, Moody J, Lee B, Port SC, Turkington TG, Beanlands RS, deKemp RA. Characterization of 3-Dimensional PET Systems for Accurate Quantification of Myocardial Blood Flow. J Nucl Med. 2017 Jan;58(1):103-109. doi: 10.2967/jnumed.116.174565. Epub 2016 Aug 18.

Reference Type: RESULT

PMID: 27539843 (View on PubMed)

Murthy VL, Naya M, Foster CR, Hainer J, Gaber M, Di Carli G, Blankstein R, Dorbala S, Sitek A, Pencina MJ, Di Carli MF. Improved cardiac risk assessment with noninvasive measures of coronary flow reserve. Circulation. 2011 Nov 15;124(20):2215-24. doi: 10.1161/CIRCULATIONAHA.111.050427. Epub 2011 Oct 17.

Reference Type: RESULT

PMID: 22007073 (View on PubMed)

Ziadi MC, Dekemp RA, Williams KA, Guo A, Chow BJ, Renaud JM, Ruddy TD, Sarveswaran N, Tee RE, Beanlands RS. Impaired myocardial flow reserve on rubidium-82 positron emission tomography imaging predicts adverse outcomes in patients assessed for myocardial ischemia. J Am Coll Cardiol. 2011 Aug 9;58(7):740-8. doi: 10.1016/j.jacc.2011.01.065.

Reference Type: RESULT

PMID: 21816311 (View on PubMed)

Other Identifiers

Pro00042364

Identifier Type: -

Identifier Source: org_study_id