NCT01368237

Brief Summary

Recent advances in technology have resulted in the development of scanners that can image the heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. Further advances in technology allow the visualisation of both the blood vessels and the supply of blood to the heart muscle. Here we propose to assess the latest and most powerful computed tomography scanner and compare it to magnetic resonance and conventional coronary angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 25, 2018

Status Verified

October 1, 2014

Enrollment Period

8.1 years

First QC Date

June 6, 2011

Last Update Submit

June 21, 2018

Conditions

Coronary Heart Disease

Keywords

Computed tomographyMyocardial perfusionCoronary heart disease

Outcome Measures

Primary Outcomes (1)

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

    The primary outcome measure is to establish whether 320-multidetector computed tomography can identify myocardial perfusion defects as compared to the gold standards of 3Tesla magnetic resonance imaging and fractional flow reserve measured during invasive coronary angiography.

    1 month

Secondary Outcomes (4)

  • Identification of regional wall motion abnormalities qualitatively by trained observers

    1 month

  • Identification of infarction qualitatively by trained observers

    1 month

  • Identification of regional wall motion abnormalities quantitatively by computer software

    1 month

  • Identification of infarction qualitatively by computer software

    1 month

Study Arms (1)

Patients

Patients awaiting invasive coronary angiography

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 imaging of myocardial perfusion, function and viability.

Patients

Eligibility Criteria

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

Patients awaiting invasive coronary angiography

You may qualify if:

  • referred for invasive coronary angiography because of suspected coronary heart disease

You may not qualify if:

  • inability or unwillingness to undergo computed tomography or magnetic resonance imaging
  • renal failure (serum creatinine \>200 micromol/L or estimated glomerular filtration rate \<30 mL/min)
  • hepatic failure
  • allergy to iodinated contrast or gadolinium
  • pregnancy
  • contraindication to adenosine infusion
  • inability to give informed consent
  • inability to perform fractional flow reserve during invasive coronary angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Location

Related Publications (1)

  • Papanastasiou G, Williams MC, Dweck MR, Alam S, Cooper A, Mirsadraee S, Newby DE, Semple SI. Quantitative assessment of myocardial blood flow in coronary artery disease by cardiovascular magnetic resonance: comparison of Fermi and distributed parameter modeling against invasive methods. J Cardiovasc Magn Reson. 2016 Sep 13;18(1):57. doi: 10.1186/s12968-016-0270-1.

    PMID: 27624746DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • David E Newby

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 7, 2011

Study Start

May 1, 2006

Primary Completion

June 1, 2014

Study Completion

January 1, 2017

Last Updated

June 25, 2018

Record last verified: 2014-10

Locations

GB(1)