History of Myocardial InfarctionPIAFNCT05138718
FDG an Myocardial Infarction: The PIAF Trial
An observational study of History of Myocardial Infarction, run by International Atomic Energy Agency at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- History of Myocardial Infarction
- What is being tested?
- 18F-FDG PET/CT
- How many people
- 2,041 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Willing and able to provide written informed consent
- 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
- 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
- If after 6 months of patient recruitment it is foreseeable that the target number of patients will not be reached, patients who undergo FDG PET/CT imaging for cancer screening or surveillance can be included, provided that they have no evidence of an active malignancy on the scan or other exclusion criteria as listed below at study entry, including recent radio- and / or chemotherapy (≥ 12 months before the FDG PET/CT)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital, Havard Medical School
Boston, Massachusetts, 02115
Ahmed Tawakol, MD, PhD, atawakol@mgh.harvard.edu
About this study
Official title: International Multicenter Trial on the Prognostic Value of Arterial 18F-FDG PET Imaging in Patients With History of Myocardial Infarction
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.
Read the detailed description
From a clinical perspective, atherosclerosis leading to arterial plaque rupture is one of the most important causes of death that still misses a personalized, reliable and quantitative assessment of risk. This is particularly true for patients who suffered from a non-fatal coronary syndrome, were recent studies described severe CVD event rates of up to 5 % per year despite the use of aggressive secondary prevention strategies.
While in previous clinical interventional trials inflammatory atherosclerotic activity was mainly determined by the surrogate marker high-sensitivity C-reactive protein, other studies have shown superiority of FDG PET/CT in the stratification of patients in high versus low risk groups, where risk in the highest (vs. lowest) TBR tertile was approximately 3-fold greater compared with what has been historically observed for the inflammatory blood biomarker, hsCRP. It is, thus, expected that imaging (vs. blood) biomarkers provide additional prognostic information that is more relevant to the artery wall per se, whereas currently used blood biomarkers carry information from vascular as well as nonvascular sources.
The current research aims at identifying distinct and reliable FDG PET threshold values, which specify the individual risk of a distinct patient. For this purpose, a well-designed and well-powered multicenter trial is needed.
Fundamentally, the research project aims at evaluating the prognostic value of arterial FDG PET/CT imaging of individuals with known cardiovascular disease (CVD). Specifically, we will:
- Test the hypothesis that the baseline measures of arterial inflammation (as assessed by FDG PET/CT) independently predict the risk of CVD events (as coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, revascularization, or heart failure) in a large cohort of individuals with prior MI.
- Evaluate the incremental prognostic value of arterial inflammation (PET) over circulating blood biomarkers
- Evaluate the prognostic value of inflammation data derived from various arterial locations (e.g. aorta, carotids, or other locations) for their ability to predict severe cardiovascular events
- Identify cut-off values that indicate higher risk
- Evaluate the predicted value of specific brain uptake, hematopoietic tissue (spleen, bone marrow) and visceral adipose tissue on emerging CV events. Evaluate the added value of combining those uptake values with arterial uptake
- Evaluate the different established arterial FDG uptake parameters with regards to standardization and scanner type/variability
- Apply deep-learning algorithms for detection of organ/tissue interactions and CV event hypothesis generation
- Evaluate a subset of patients for inter-observer variability
- Evaluate the detection rate of incidental PET/CT findings in the study cohort (suspected malignancies, other diseases)
- Suggest novel diagnostic algorithms and clinical protocols accordingly
- Evaluate the prognostic value of additionally derived genetic markers.
- Specifically, we propose that patients with higher GRS have increased FDG PET/CT based inflammatory atherosclerotic activity and are prone to more MACE
- Conditions
- History of Myocardial Infarction
- Being tested
- 18F-FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDiagnostic test
Perform a 18F-FDG PET/CT to patients with history of myocardial infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 to 5 years follow-up period
Secondary outcomes (2)
Other cardiovascular events
coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure
Measured: 4 to 5 years follow-up period
All-causes of death
All-causes of death
Measured: 4 to 5 years follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for History of Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,041 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Francesco Giammarile, International Atomic Energy Agency
- Investigators
- Francesco Giammarile, MD, PhD, Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138718
- Sponsor's protocol ID
- CRP13048
- Acronym
- PIAF
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29175654Figueroa 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.
PubMed 24269261Duivenvoorden 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.
PubMed 24135322Nitta 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.
PubMed 24229770Noh 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.
PubMed 24179183Hetterich 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.
PubMed 25898891D'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.
PubMed 18212285
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Trial on the Prognostic Value of Arterial 18F-FDG PET Imaging in Patients With History of Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05138718
- Acronym / sponsor ID
- PIAF / CRP13048
- Conditions
- History of Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,041 participants (estimated)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
From a clinical perspective, atherosclerosis leading to arterial plaque rupture is one of the most important causes of death that still misses a personalized, reliable and quantitative assessment of risk. This is particularly true for patients who suffered from a non-fatal coronary syndrome, were recent studies described severe CVD event rates of up to 5 % per year despite the use of aggressive secondary prevention strategies.
While in previous clinical interventional trials inflammatory atherosclerotic activity was mainly determined by the surrogate marker high-sensitivity C-reactive protein, other studies have shown superiority of FDG PET/CT in the stratification of patients in high versus low risk groups, where risk in the highest (vs. lowest) TBR tertile was approximately 3-fold greater compared with what has been historically observed for the inflammatory blood biomarker, hsCRP. It is, thus, expected that imaging (vs. blood) biomarkers provide additional prognostic information that is more relevant to the artery wall per se, whereas currently used blood biomarkers carry information from vascular as well as nonvascular sources.
The current research aims at identifying distinct and reliable FDG PET threshold values, which specify the individual risk of a distinct patient. For this purpose, a well-designed and well-powered multicenter trial is needed.
Fundamentally, the research project aims at evaluating the prognostic value of arterial FDG PET/CT imaging of individuals with known cardiovascular disease (CVD). Specifically, we will:
- Test the hypothesis that the baseline measures of arterial inflammation (as assessed by FDG PET/CT) independently predict the risk of CVD events (as coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, revascularization, or heart failure) in a large cohort of individuals with prior MI.
- Evaluate the incremental prognostic value of arterial inflammation (PET) over circulating blood biomarkers
- Evaluate the prognostic value of inflammation data derived from various arterial locations (e.g. aorta, carotids, or other locations) for their ability to predict severe cardiovascular events
- Identify cut-off values that indicate higher risk
- Evaluate the predicted value of specific brain uptake, hematopoietic tissue (spleen, bone marrow) and visceral adipose tissue on emerging CV events. Evaluate the added value of combining those uptake values with arterial uptake
- Evaluate the different established arterial FDG uptake parameters with regards to standardization and scanner type/variability
- Apply deep-learning algorithms for detection of organ/tissue interactions and CV event hypothesis generation
- Evaluate a subset of patients for inter-observer variability
- Evaluate the detection rate of incidental PET/CT findings in the study cohort (suspected malignancies, other diseases)
- Suggest novel diagnostic algorithms and clinical protocols accordingly
- Evaluate the prognostic value of additionally derived genetic markers.
- Specifically, we propose that patients with higher GRS have increased FDG PET/CT based inflammatory atherosclerotic activity and are prone to more MACE
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent
- 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
- Female patients must not be pregnant at the time of FDG PET/CT imaging
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTPerform a 18F-FDG PET/CT to patients with history of myocardial infarction | Diagnostic test | – |
Primary outcome
Cardiovascular events
Time frame: 4 to 5 years follow-up period
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
2 secondary outcomes
Other cardiovascular events
Time frame: 4 to 5 years follow-up period
All-causes of death
Time frame: 4 to 5 years follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Background: PubMed 29175654Iwatsuka 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.
- Background: PubMed 24269261Figueroa 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.
- Background: PubMed 24135322Duivenvoorden 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.
- Background: PubMed 24229770Nitta 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.
- Background: PubMed 24179183Noh 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.
- Background: PubMed 25898891Hetterich 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.
- Results publication: PubMed 18212285D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Giammarile, MD, PhD study director
International Atomic Energy Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of History of Myocardial Infarction, run by International Atomic Energy Agency at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Giammarile, MD, PhD (+436606820396, f.giammarile@iaea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 4 to 5 years follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138718, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.