NCT01476579

Brief Summary

This study is evaluating the performance of modern CT coronar angiography with low radiation technique compared to conventional invasive coronar angiography. The patients recruited will already be accepted for invasive coronary angiography based on clinical presentation, ECG and biochemical parameters. An "all-comers" design to avoid selection bias and no additional B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to rule out significant coronary artery disease with sensitivity \> 95 % and negative predictive value \> 95 % with very low radiation doses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
769

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 9, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

November 9, 2011

Last Update Submit

April 16, 2019

Conditions

Coronary Artery Disease

Keywords

Coronary CTSensitivitySpecificityRadiationTomography, X-Ray ComputedCoronary angiography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity

    The results from the CT coronary angiography will be compared with the results from the conventional invasive coronary angiography which in this respect is considered the "gold standard". The sensitivity and specificity for the CT angiography regarding detection of significant coronary stenosis (ie more than 50 % lumen narrowing with the angiographic result as reference) and for revascularisation will be calculated separately.

    24 hours

Secondary Outcomes (4)

  • Change in quality of life and symptom score

    6 months, 1 and 3 years

  • Coronary calcium score impact on pretest coronary risk scoring and prognosis

    24 hours, 5 and 10 years

  • Vitamin D and other novel cardiovascular risk factors

    24 hours, 5 and 10 years

  • Real life radiation risk with new CT scanners and conventional invasive angiography

    24 hours

Study Arms (1)

Non-invasive CT coronary angiography

OTHER

This study is evaluating diagnostic accuracy of non-invasive CT coronary angiography with invasive coronary angiography.

Device: Cardiac Computer Tomography

Interventions

Cardiac Computer TomographyDEVICE

Compare Cardiac CT with reference standard wich is conventional invasive coronary angiography.

Non-invasive CT coronary angiography

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 800 Patients who are scheduled to undergo conventional invasive coronary angiogram will be recruited at the University hospital of North Norway, Tromsø.

You may not qualify if:

  • Acute coronary syndrome with positive high sensitive troponin.
  • Renal failure with glomerular filtration rate (GFR) \< 30
  • Contraindication to contrast medium
  • Symptomatic Tachycardia \>110 or bradycardia \< 40
  • Pregnancy
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHypersensitivity

Interventions

Cardiac-Gated Single-Photon Emission Computer-Assisted Tomography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac-Gated Imaging TechniquesCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • AMJID IQBAL, MD, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 22, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2022

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

NO(1)