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OpenTrials
Completed

NCT Number: NCT01211548

Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

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.)

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Key information

Conditions

Complex Aortic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

contrast CTA of the CAP

Other

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

Primary outcomes

  1. The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: CARE

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 29, 2010
Registry last updated
Mar 7, 2017

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.