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Natural History of Carotid Plaque as Determined by 3D Ultrasound

NCT03314818 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2017-10-19

No results posted yet for this study

Summary

This proposed follow-up study aims to recruit participants from the original BioImage cohort for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will provide information on the natural history of carotid atherosclerosis and factors that contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for 5 years to continue to monitor claims and other information for major cardiovascular events, other outcomes and healthcare utilization.

Conditions

  • Atherosclerotic Disease
  • Plaque, Atherosclerotic
  • Heart Diseases
  • Stroke
  • Cardiovascular Risk Factor

Interventions

DEVICE

Ultrasound 3D Imaging

Carotid artery ultrasound will be used to: Determine plaque presence and plaque burden Presence of stenosis Additionally, Carotid Intima-Media Thickness (IMT) will be measured and aortic diameter will be measured by abdominal aortic ultrasound scanning. Ultrasound of the Abdominal Aorta will be used to determine the presence and severity of stenosis or aneurism.

Sponsors & Collaborators

Principal Investigators

  • Valentin Fuster, M.D. · Icahn School of Medicine at Mount Sinai

  • Pieter Muntendam, M.D. · BioImage-2 LLC

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2018-09-22
Completion
2023-10-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314818 on ClinicalTrials.gov