NCT01963221

Brief Summary

The purpose of this study is to determine the relationship between thoracic aortic inflammation and arterial stiffness in elderly patients. Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested to exert pro-inflammatory actions threw several biological mediators enhancing arterial stiffness. Both effects of aging and hypertension are associated with higher levels of arterial stiffness, but their respective role is not well established in the pathophysiology of arterial stiffening. Few data are available neither on the real anatomic aortic impact of aging and hypertension on aortic compliance and ventricular function and its relationship to arterial stiffness assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase contrast magnetic resonance imaging arterial stiffness measurements. Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose (FDG) has been advocated as a means of measuring arterial wall inflammation in various population referred for oncology staging. FDG uptake is correlated with the number of cardiovascular risk factors and even the risk of future cardiovascular events. This method, combined with X-ray computed tomography (CT), has also demonstrated that aortic calcifications quantified by CT and local signs of inflammation detected by FDG uptake contribute to arterial stiffness. A strong relationship between large vessels stiffening assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications quantified by CT and inflammation evaluated by FDG uptake has been demonstrated. Therefore, in the current study, we use FDG PET associated to CT to characterize aortic inflammation and aortic calcifications coupled to pulse wave velocity measurement and cardiac function in elderly individuals. In fact, if vascular aging promoting a local inflammatory process is a risk factor for cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio), predictors of cardiovascular mortality were also quantified. Thoracic aorta local inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation (high-sensitivity C-reactive protein, interleukin 6 were also determined).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

October 6, 2013

Last Update Submit

October 13, 2013

Conditions

Keywords

elderlyaortainflammationarterial stiffnessPET/CT ImaginghypertensionMRI

Outcome Measures

Primary Outcomes (1)

  • Aortic inflammation assessed by 18 F FDG maximal standard uptake value measurement

    Combined FDG PET/CT imaging was performed using a hybrid scanner hybrid system. For analysis, the thoracic aorta was divided into three segments: the ascending aorta, the aortic arch and the descending aorta. The standard uptake value (SUV) was calculated by dividing the activity measured in each voxel by the total injected activity, which was expressed per g of body weight and corrected for radioactive decay. Aortic activity was quantified using a conventional method on consecutive slices, which were orientated perpendicular to the aorta like described in previous publication. Region of interest (ROI) were drawn around the aorta on each trans-axial slice, allowing mean (SUVmean) and maximal aortic SUV (SUVmax) to be determined on every slice. These values were averaged to determine SUVmean and SUVmax for the ascending aorta, the aortic arch and the descending aorta. All PET scans were analyzed independently by two trained observers (VR, PM).

    one year

Secondary Outcomes (1)

  • parietal thoracic aorta volume of calcification measured by computed tomography

    one year

Other Outcomes (1)

  • carotid femoral pulse wave velocity

    at the time of the measurement

Study Arms (1)

fluodeoxyglucose (18f)

OTHER
Radiation: fludeoxyglucose(18f)Other: blood sampleOther: cardiac and aortic magnetic resonance imagingOther: carotid femoral pulse wave velocityRadiation: positron emission tomographyRadiation: computed tomography

Interventions

Also known as: GLUSCAN, solution for injection, 600 MBq/ml : 564 461-8, ADVANCED ACCELERATOR APPLICATIONS (AAA) Laboratory
fluodeoxyglucose (18f)
fluodeoxyglucose (18f)
fluodeoxyglucose (18f)
fluodeoxyglucose (18f)
fluodeoxyglucose (18f)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \>=65 years old

You may not qualify if:

  • blood glucose\> 200 mg/dl before the PET/CT scanning
  • inflammatory disease
  • cancer
  • all forms of secondary hypertension
  • renal hepatic or pulmonary insufficiency
  • absence of cardiac sinus rhythm
  • diabetes mellitus
  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Joly L, Mandry D, Verger A, Labat C, Watfa G, Roux V, Karcher G, Marie PY, Benetos A. Influence of Thoracic Aortic Inflammation and Calcifications on Arterial Stiffness and Cardiac Function in Older Subjects. J Nutr Health Aging. 2016 Mar;20(3):347-54. doi: 10.1007/s12603-015-0574-0.

MeSH Terms

Conditions

InflammationHypertension

Interventions

Fluorodeoxyglucose F18SolutionsInjectionsLaboratoriesBlood Specimen CollectionMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeuticsNon-Medical Public and Private FacilitiesHealth FacilitiesHealth Care Facilities Workforce and ServicesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Laure JOLY, MD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MCU-PH, MD, PhD

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 16, 2013

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations