FDG an Myocardial Infarction: The PIAF Trial

NCT05138718 | Recruiting DMC

• 1 other identifier: CRP13048
• Study Type: observational
• Target: 2,041
• Locations: 1 country
• Sites: 1

Brief Summary

In order to define distinct and reliable arterial 18Fluorodeoxyglucose (FDG) thresholds identifying patients at risk for cardiovascular events, patients with a history of myocardial infarction will be included in this international multicenter trial. Non-enhanced whole-body FDG PET/CT will be performed in all patients and the arterial FDG uptake in the carotid arteries as well as the aorta will be quantified by calculating different uptake parameters. In addition, FDG uptake in hematopoietic tissues (spleen, bone marrow), visceral adipose tissue (VAT) and different brain regions (e. g. amygdala) will be measured. Furthermore, specific blood biomarkers including genetic biomarkers, which are linked to atherosclerotic disease with predictive power for future cardiovascular events, will be analyzed in a subgroup of patients. In part 2 of the trial, a 4-year follow-up period will be analyzed with a focus on the prediction of cardiovascular events (acute coronary syndrome, non-fatal ischemic stroke, ischemic cardiac death, other causes of death, coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure). The predictive value of the arterial, hematopoietic and cerebral FDG uptake parameters as well as of the specific blood and genetic biomarkers will be determined.

Conditions

History of Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Cardiovascular events considered will be: coronary death, myocardial infarction, coronary insufficiency/acute coronary syndrome, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, revascularization, or heart failure

  4 to 5 years follow-up period

Secondary Outcomes (2)

• Other cardiovascular events

  4 to 5 years follow-up period

• All-causes of death

  4 to 5 years follow-up period

Interventions

18F-FDG PET/CT DIAGNOSTIC_TEST

Perform a 18F-FDG PET/CT to patients with history of myocardial infarction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients 18-80 years of age * Patients with documented myocardial infarction \> 90 days before study inclusion * Clinically stable at the time of screening and able to tolerate the study procedure

You may qualify if:

• Willing and able to provide written informed consent
• Patients 18-80 years of age
• Clinically stable at the time of screening and able to tolerate the study procedure
• Female patients must not be pregnant at the time of FDG PET/CT imaging
• Patients included in other clinical trials could be included, provided this complies with specific local and research center requirements

You may not qualify if:

• Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema)
• Extra-cardiac illness that is expected to limit survival to less than 4-5 years; e. g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or severe hepatic dysfunction, severe renal disease, active cancer
• Patients with chronic use of anti-inflammatory medication (except NSAIDs and inhaled corticosteroids)
• Patients with Diabetes Type I
• Insulin-dependent or uncontrolled Diabetes Type II (as HbA1C\>7.5)
• Withdrawal of Informed consent

Sponsors & Collaborators

• International Atomic Energy Agency: lead

Study Sites (1)

Massachusetts General Hospital, Havard Medical School

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (7)

• Iwatsuka R, Matsue Y, Yonetsu T, O'uchi T, Matsumura A, Hashimoto Y, Hirao K. Arterial inflammation measured by 18F-FDG-PET-CT to predict coronary events in older subjects. Atherosclerosis. 2018 Jan;268:49-54. doi: 10.1016/j.atherosclerosis.2017.11.016. Epub 2017 Nov 21.

  PMID: 29175654 BACKGROUND

• Figueroa AL, Abdelbaky A, Truong QA, Corsini E, MacNabb MH, Lavender ZR, Lawler MA, Grinspoon SK, Brady TJ, Nasir K, Hoffmann U, Tawakol A. Measurement of arterial activity on routine FDG PET/CT images improves prediction of risk of future CV events. JACC Cardiovasc Imaging. 2013 Dec;6(12):1250-9. doi: 10.1016/j.jcmg.2013.08.006. Epub 2013 Oct 23.

  PMID: 24269261 BACKGROUND

• Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009.

  PMID: 24135322 BACKGROUND

• Nitta Y, Tahara N, Tahara A, Honda A, Kodama N, Mizoguchi M, Kaida H, Ishibashi M, Hayabuchi N, Ikeda H, Yamagishi S, Imaizumi T. Pioglitazone decreases coronary artery inflammation in impaired glucose tolerance and diabetes mellitus: evaluation by FDG-PET/CT imaging. JACC Cardiovasc Imaging. 2013 Nov;6(11):1172-82. doi: 10.1016/j.jcmg.2013.09.004.

  PMID: 24229770 BACKGROUND

• Noh TS, Moon SH, Cho YS, Hong SP, Lee EJ, Choi JY, Kim BT, Lee KH. Relation of carotid artery 18F-FDG uptake to C-reactive protein and Framingham risk score in a large cohort of asymptomatic adults. J Nucl Med. 2013 Dec;54(12):2070-6. doi: 10.2967/jnumed.113.119602. Epub 2013 Oct 31.

  PMID: 24179183 BACKGROUND

• Hetterich H, Rominger A, Walter L, Habs M, Volpers S, Hacker M, Reiser MF, Bartenstein P, Saam T. Natural history of atherosclerotic disease progression as assessed by (18)F-FDG PET/CT. Int J Cardiovasc Imaging. 2016 Jan;32(1):49-59. doi: 10.1007/s10554-015-0660-8. Epub 2015 Apr 22.

  PMID: 25898891 BACKGROUND

• D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.

  PMID: 18212285 RESULT

Study Officials

• Francesco Giammarile, MD, PhD

  International Atomic Energy Agency

  STUDY DIRECTOR

Central Study Contacts

Francesco Giammarile, MD, PhD

CONTACT

+436606820396; f.giammarile@iaea.org

Diana Paez, MD

CONTACT

+4316521670; d.paez@iaea.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine Physician

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)