Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach (CARE)

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.)

Study Overview

• Status: Completed
• Conditions: Complex Aortic Surgery
• Intervention / Treatment: Other: contrast CTA of the CAP

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.

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: contrast CTA of the CAP; CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: 10-573; PVSS1005TM (Other Grant/Funding Number: PVSS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO