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320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery

This study has been withdrawn prior to enrollment.
(Not funded.)
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01169948
First received: July 14, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.


Condition Intervention
Coronary Disease
 Radiation: Computed tomography scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 320 Multidetector Computed Tomography in the Preoperative Assessment for Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2010
Groups/Cohorts Assigned Interventions
Patients awaiting cardiac surgery Radiation: Computed tomography scan
Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients awaiting cardiac surgery.

Criteria

Inclusion Criteria:

  • patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement

Exclusion Criteria:

  • age less than 18
  • pregnancy or breast feeding
  • inability to undergo computed tomography scanning
  • inability to give informed consent
  • severe renal failure (serum creatinine >250umol/l or estimated glomerular filtration rate <15ml/min)
  • known allergy to iodinated contrast
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169948

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: David E Newby, PhD BM DM University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01169948     History of Changes
Other Study ID Numbers: 2009/R/CAR/17
Study First Received: July 14, 2010
Last Updated: March 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Coronary disease
Coronary artery bypass
Cardiac surgery
Computed tomography
Coronary angiography

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on June 18, 2013