Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

Complex Aortic Surgery Clinical Trial

— CARE  

Official title:

Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211548
• Other study ID #: 10-573
• Secondary ID: PVSS1005TM
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: March 6, 2017
• Start date: February 2011
• Est. completion date: July 2011

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Complex Aortic Surgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.		6 months