Magnetic Resonance Imaging of Aortic Aneurysm Instability

NCT00794092 | Completed Phase 2

• 1 other identifier: 2007/R/CAR/15
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. In this study, the investigators hope to develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped that this scan will be better at determining which AAAs are at risk of bursting and therefore require an operation to prevent this.

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Change in signal intensity in a Region of Interest on MRI scanning

  24 hours after administration of Sinerem

Study Arms (1)

Sinerem

EXPERIMENTAL

MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem

Drug: Sinerem administration

Interventions

Sinerem administration DRUG

Single dose

Sinerem

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AAA measuring \>40mm in AP diameter on ultrasound scanning
• Age \>40 years (patients younger than this with AAA may have a connective tissue disorder and a different aetiology to their disease)
• Considered to be suitable for standard infra-renal open surgical repair

You may not qualify if:

• Patients who are not deemed to be fit for open surgical repair
• Patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation
• Contraindication to MRI scanning identified from MRI Safety Questionnaire (see attached)or claustrophobia
• Age \<40 years
• Patients requiring emergent repair such that there is insufficient time available to complete the protocol
• Patients refusing to give consent
• Patients unable to give consent
• Pregnant women (contrast is teratogenic in animals)
• Intercurrent illness (may confound the results)
• Patients with a systemic inflammatory disorder or underlying malignancy
• Patients who require an emergency operation such that there is insufficient time to complete the study protocol
• Renal dysfunction (Creat \>250 or eGFR\<25)
• Hepatic dysfunction (Child's grade B or C)

Sponsors & Collaborators

• University of Edinburgh: lead
• British Heart Foundation: collaborator

Study Sites (1)

University of Edinburgh/Royal Infirmary of Edinburgh

Edinburgh, Midlothian, Eh16 4SA, United Kingdom

Location

Related Publications (1)

• Richards JM, Semple SI, MacGillivray TJ, Gray C, Langrish JP, Williams M, Dweck M, Wallace W, McKillop G, Chalmers RT, Garden OJ, Newby DE. Abdominal aortic aneurysm growth predicted by uptake of ultrasmall superparamagnetic particles of iron oxide: a pilot study. Circ Cardiovasc Imaging. 2011 May;4(3):274-81. doi: 10.1161/CIRCIMAGING.110.959866. Epub 2011 Feb 8.

  PMID: 21304070 RESULT

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• David E Newby

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

GB (1)