Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

NCT ID: NCT01211548

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-07-31

Brief Summary

This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)

Detailed Description

This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.

Conditions

Complex Aortic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

contrast CTA of the CAP

All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients.

contrast CTA of the CAP

Intervention Type: OTHER

CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.

Interventions

contrast CTA of the CAP

CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis

Exclusion Criteria

• Patients with contraindications to undergoing CT coronary angiography
• coronary revascularization within the last six months
• renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PVSS1005TM

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-573

Identifier Type: -

Identifier Source: org_study_id