Peripheral Arterial DiseasePhase 1AIIRESNCT03590769
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
A Phase 1 study testing 18F-FDG in people with Peripheral Arterial Disease and Claudication, Intermittent, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Intermittent, Claudication
- What is being tested?
- 18F-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2017to 3 Sep 2019
- Phase
- Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 40,
- With resting or exercise ABI <0.9, TBI <0.6
- Have claudication or limb threatening ischemia \& planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.
Who cannot join
- Evidence of active infection
- Hypersensitivity or allergy to contrast agents
- Chronic liver disease, renal disease (GFR< 30) or chronic inflammatory disorders
- Insulin dependent diabetes
- Presence of metal within subject's body, pacemakers, or defibrillators
- BMI < 20 or >35
Show all 10Show fewer
- Recent other major surgery or illness within 30 days
- Use of immunosuppressive medications or steroids
- History of organ transplantation
- Pregnancy, or plans to become pregnant, or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco General Hospital
San Francisco, California, 94110
UCSF
San Francisco, California, 94143
About this study
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.
Read the detailed description
Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo.
Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages.
When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site.
This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.
- Conditions
- Peripheral Arterial Disease, Claudication, Intermittent, Claudication, PAD, SFA - Superficial Femoral Artery Stenosis, Iliac Artery Disease
- Being tested
- 18F-FDG
- Keywords
- Peripheral Arterial Disease, PAD, Claudication, Intermittent, Claudication, SFA Occlusion, Arterial Occlusion, Iliac Artery Occlusion, Vascular Calcification
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Calcification, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG
| Study group | Role | What they receive |
|---|---|---|
| PET/MR using FDG-18 radiotracer | Experimental | Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.
Measured: 1 time each week for 3 weeks
Secondary outcomes (1)
Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.
Venipuncture of subject and collection of blood allows measures pro-inflammatory markers and targeted metabolipodimics.
Measured: 1 time each week for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Jun 2017
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient undergoing percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA, will have 18F-FDG-PET scan at the region of interest before intervention, then post-operatively 1 day and 1 week from treatment.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Conte, M.D., Principal investigator, University of California, San FranciscoMiguel H Pampaloni, M.D., PhD., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590769
- Sponsor's protocol ID
- 16-21018
- Acronym
- AIIRES
- Status last verified
- Nov 2020
- First submitted
- 16 May 2018
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong EJ, Chen DC, Westin GG, Singh S, McCoach CE, Bang H, Yeo KK, Anderson D, Amsterdam EA, Laird JR. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. J Am Heart Assoc. 2014 Apr 10;3(2):e000697. doi: 10.1161/JAHA.113.000697.
PubMed 24721799Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
PubMed 23915883Conen D, Rexrode KM, Creager MA, Ridker PM, Pradhan AD. Metabolic syndrome, inflammation, and risk of symptomatic peripheral artery disease in women: a prospective study. Circulation. 2009 Sep 22;120(12):1041-7. doi: 10.1161/CIRCULATIONAHA.109.863092. Epub 2009 Sep 8.
PubMed 19738135Owens CD, Ridker PM, Belkin M, Hamdan AD, Pomposelli F, Logerfo F, Creager MA, Conte MS. Elevated C-reactive protein levels are associated with postoperative events in patients undergoing lower extremity vein bypass surgery. J Vasc Surg. 2007 Jan;45(1):2-9; discussion 9. doi: 10.1016/j.jvs.2006.08.048. Epub 2006 Nov 21.
PubMed 17123769Vidula H, Tian L, Liu K, Criqui MH, Ferrucci L, Pearce WH, Greenland P, Green D, Tan J, Garside DB, Guralnik J, Ridker PM, Rifai N, McDermott MM. Biomarkers of inflammation and thrombosis as predictors of near-term mortality in patients with peripheral arterial disease: a cohort study. Ann Intern Med. 2008 Jan 15;148(2):85-93. doi: 10.7326/0003-4819-148-2-200801150-00003.
PubMed 18195333Carriere I, Dupuy AM, Lacroux A, Cristol JP, Delcourt C; Pathologies Oculaires Liees a l'Age Study Group. Biomarkers of inflammation and malnutrition associated with early death in healthy elderly people. J Am Geriatr Soc. 2008 May;56(5):840-6. doi: 10.1111/j.1532-5415.2008.01677.x. Epub 2008 Apr 9.
PubMed 18410327Criqui MH, Ho LA, Denenberg JO, Ridker PM, Wassel CL, McDermott MM. Biomarkers in peripheral arterial disease patients and near- and longer-term mortality. J Vasc Surg. 2010 Jul;52(1):85-90. doi: 10.1016/j.jvs.2010.02.004. Epub 2010 May 14.
PubMed 20471776Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Plasma concentration of C-reactive protein and risk of developing peripheral vascular disease. Circulation. 1998 Feb 10;97(5):425-8. doi: 10.1161/01.cir.97.5.425.
PubMed 9490235Ridker PM, Stampfer MJ, Rifai N. Novel risk factors for systemic atherosclerosis: a comparison of C-reactive protein, fibrinogen, homocysteine, lipoprotein(a), and standard cholesterol screening as predictors of peripheral arterial disease. JAMA. 2001 May 16;285(19):2481-5. doi: 10.1001/jama.285.19.2481.
PubMed 11368701Beckman JA, Preis O, Ridker PM, Gerhard-Herman M. Comparison of usefulness of inflammatory markers in patients with versus without peripheral arterial disease in predicting adverse cardiovascular outcomes (myocardial infarction, stroke, and death). Am J Cardiol. 2005 Nov 15;96(10):1374-8. doi: 10.1016/j.amjcard.2005.07.041. Epub 2005 Sep 27.
PubMed 16275181Tzoulaki I, Murray GD, Lee AJ, Rumley A, Lowe GD, Fowkes FG. C-reactive protein, interleukin-6, and soluble adhesion molecules as predictors of progressive peripheral atherosclerosis in the general population: Edinburgh Artery Study. Circulation. 2005 Aug 16;112(7):976-83. doi: 10.1161/CIRCULATIONAHA.104.513085. Epub 2005 Aug 8.
PubMed 16087797Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Ho KJ, Spite M, Owens CD, Lancero H, Kroemer AH, Pande R, Creager MA, Serhan CN, Conte MS. Aspirin-triggered lipoxin and resolvin E1 modulate vascular smooth muscle phenotype and correlate with peripheral atherosclerosis. Am J Pathol. 2010 Oct;177(4):2116-23. doi: 10.2353/ajpath.2010.091082. Epub 2010 Aug 13.
PubMed 20709806Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2.
PubMed 23830313Owens CD, Wake N, Conte MS, Gerhard-Herman M, Beckman JA. In vivo human lower extremity saphenous vein bypass grafts manifest flow mediated vasodilation. J Vasc Surg. 2009 Nov;50(5):1063-70. doi: 10.1016/j.jvs.2009.06.022. Epub 2009 Aug 12.
PubMed 19679424
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
- ClinicalTrials.gov ID
- NCT03590769
- Acronym / sponsor ID
- AIIRES / 16-21018
- Conditions
- Peripheral Arterial Disease, Claudication, Intermittent, Claudication, PAD, SFA - Superficial Femoral Artery Stenosis, Iliac Artery Disease
- Keywords
- Peripheral Arterial Disease, PAD, Claudication, Intermittent, Claudication, SFA Occlusion, Arterial Occlusion, Iliac Artery Occlusion, Vascular Calcification
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 18 Jul 2018 (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.
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.
Detailed description
Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo.
Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages.
When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site.
This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient undergoing percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA, will have 18F-FDG-PET scan at the region of interest before intervention, then post-operatively 1 day and 1 week from treatment.
| Arm | Type | Receives |
|---|---|---|
| PET/MR using FDG-18 radiotracer | Experimental | Drug: 18F-FDGUsing FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 40,
- With resting or exercise ABI <0.9, TBI <0.6
- Have claudication or limb threatening ischemia \& planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.
Key exclusion criteria (10 listed)
- Evidence of active infection
- Hypersensitivity or allergy to contrast agents
- Chronic liver disease, renal disease (GFR< 30) or chronic inflammatory disorders
- Insulin dependent diabetes
- Presence of metal within subject's body, pacemakers, or defibrillators
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-FDGAll subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG | Drug | PET/MR using FDG-18 radiotracer |
Primary outcome
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
Time frame: 1 time each week for 3 weeks
Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.
1 secondary outcome
Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.
Time frame: 1 time each week for 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 24721799Armstrong EJ, Chen DC, Westin GG, Singh S, McCoach CE, Bang H, Yeo KK, Anderson D, Amsterdam EA, Laird JR. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. J Am Heart Assoc. 2014 Apr 10;3(2):e000697. doi: 10.1161/JAHA.113.000697.
- Background: PubMed 23915883Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Background: PubMed 19738135Conen D, Rexrode KM, Creager MA, Ridker PM, Pradhan AD. Metabolic syndrome, inflammation, and risk of symptomatic peripheral artery disease in women: a prospective study. Circulation. 2009 Sep 22;120(12):1041-7. doi: 10.1161/CIRCULATIONAHA.109.863092. Epub 2009 Sep 8.
- Background: PubMed 17123769Owens CD, Ridker PM, Belkin M, Hamdan AD, Pomposelli F, Logerfo F, Creager MA, Conte MS. Elevated C-reactive protein levels are associated with postoperative events in patients undergoing lower extremity vein bypass surgery. J Vasc Surg. 2007 Jan;45(1):2-9; discussion 9. doi: 10.1016/j.jvs.2006.08.048. Epub 2006 Nov 21.
- Background: PubMed 18195333Vidula H, Tian L, Liu K, Criqui MH, Ferrucci L, Pearce WH, Greenland P, Green D, Tan J, Garside DB, Guralnik J, Ridker PM, Rifai N, McDermott MM. Biomarkers of inflammation and thrombosis as predictors of near-term mortality in patients with peripheral arterial disease: a cohort study. Ann Intern Med. 2008 Jan 15;148(2):85-93. doi: 10.7326/0003-4819-148-2-200801150-00003.
- Background: PubMed 18410327Carriere I, Dupuy AM, Lacroux A, Cristol JP, Delcourt C; Pathologies Oculaires Liees a l'Age Study Group. Biomarkers of inflammation and malnutrition associated with early death in healthy elderly people. J Am Geriatr Soc. 2008 May;56(5):840-6. doi: 10.1111/j.1532-5415.2008.01677.x. Epub 2008 Apr 9.
- Background: PubMed 20471776Criqui MH, Ho LA, Denenberg JO, Ridker PM, Wassel CL, McDermott MM. Biomarkers in peripheral arterial disease patients and near- and longer-term mortality. J Vasc Surg. 2010 Jul;52(1):85-90. doi: 10.1016/j.jvs.2010.02.004. Epub 2010 May 14.
- Background: PubMed 9490235Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Plasma concentration of C-reactive protein and risk of developing peripheral vascular disease. Circulation. 1998 Feb 10;97(5):425-8. doi: 10.1161/01.cir.97.5.425.
- Background: PubMed 11368701Ridker PM, Stampfer MJ, Rifai N. Novel risk factors for systemic atherosclerosis: a comparison of C-reactive protein, fibrinogen, homocysteine, lipoprotein(a), and standard cholesterol screening as predictors of peripheral arterial disease. JAMA. 2001 May 16;285(19):2481-5. doi: 10.1001/jama.285.19.2481.
- Background: PubMed 16275181Beckman JA, Preis O, Ridker PM, Gerhard-Herman M. Comparison of usefulness of inflammatory markers in patients with versus without peripheral arterial disease in predicting adverse cardiovascular outcomes (myocardial infarction, stroke, and death). Am J Cardiol. 2005 Nov 15;96(10):1374-8. doi: 10.1016/j.amjcard.2005.07.041. Epub 2005 Sep 27.
- Background: PubMed 16087797Tzoulaki I, Murray GD, Lee AJ, Rumley A, Lowe GD, Fowkes FG. C-reactive protein, interleukin-6, and soluble adhesion molecules as predictors of progressive peripheral atherosclerosis in the general population: Edinburgh Artery Study. Circulation. 2005 Aug 16;112(7):976-83. doi: 10.1161/CIRCULATIONAHA.104.513085. Epub 2005 Aug 8.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- 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.
Michael S Conte, M.D. principal investigator
University of California, San Francisco
Miguel H Pampaloni, M.D., PhD. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-FDG in people with Peripheral Arterial Disease and Claudication, Intermittent, run by University of California, San Francisco at 2 sites 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury. (time frame: 1 time each week for 3 weeks). 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 NCT03590769, which also lists 36 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 30 Nov 2020.