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OpenTrials
Completed

NCT Number: NCT00587977

Aortic Distensibility

Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
  • BMI 31 or less.
  • Creatinine results <2.0 and within six months prior to scan.
  • US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
  • Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.

Exclusion criteria

  • Creatinine > 2.0.
  • Creatinine <0.9 or >1.4 for those who are scheduled for US.
  • Atrial fibrillation or other arrythmia.
  • Known AAA greater than 5 cm in size.
  • Allergy to contrast dye.

Treatment and study plan

Primary outcomes

  1. In year one, this data will be used to develop pulsatility software and test robustness.

    Time frame: First Year

Secondary outcomes

  1. In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm).

    Time frame: Year Two

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Flight Attendant Medical Research Institute

Registry information

Official study title

ECG-Gated Multidetector CT of Aortic Distensibility FAMRI

Acronym: FAMRI

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2008
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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