NCT01169948

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

First QC Date

July 14, 2010

Last Update Submit

March 13, 2013

Conditions

Coronary Disease

Keywords

Coronary diseaseCoronary artery bypassCardiac surgeryComputed tomographyCoronary angiography

Outcome Measures

Primary Outcomes (1)

  • Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software

    1 month

Secondary Outcomes (1)

  • Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software

    1 month

Study Arms (1)

Patients awaiting cardiac surgery

Radiation: Computed tomography scan

Interventions

Computed tomography scanRADIATION

Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.

Patients awaiting cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients awaiting cardiac surgery.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • David E Newby, PhD BM DM

    University of Edinburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 26, 2010

Study Start

June 1, 2010

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

GB(1)