NCT00627172

Brief Summary

Multislice CT angiography is a novel but already established and widely used in diagnosing coronary artery disease (CAD). It is very reliable in ruling out hemodynamically significant narrowings in coronary arteries (Negative predictive value). However, it may overestimate the severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive value 70%). However, when coupled with a functional or flow-sensitive diagnostic test, such as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be as high as 95 %. Despite this assumption, there's no scientific evidence to support use of such hybrid multi-modality tests at present. The investigators hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of coronary artery disease will decrease the proportion of patients that need catheter angiographies. The avoidance of these unnecessary invasive procedures will improve patients´ quality of life and may even redirect health care resources in a more efficient way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

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

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 11, 2008

Status Verified

August 1, 2008

First QC Date

February 20, 2008

Last Update Submit

August 8, 2008

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseMDCTPositron emission tomographyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Detection of hemodynamically significant coronary artery lesions with combined use coronary CT and PET perfusion as compared with invasive angiography combined with measurement of fractional flow reserve

    In the beginning of the study

Secondary Outcomes (2)

  • Detection of hemodynamically significant coronary artery lesions with combined use coronary CT and coronary doppler ultrasonography as compared with invasive angiography combined with measurement of fractional flow reserve

    In the beginning of the study

  • Quality of life

    Baseline and at 1 year

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chest pain

You may qualify if:

  • informed consent
  • age 40 - 80 years
  • stable chest pain
  • likelihood of obstructive coronary artery disease more than 25% based on gender, age, symptoms and exercise test

You may not qualify if:

  • irregular rhythm
  • hypersensitivity to contrast agents
  • unstable chest pain
  • decompensated congestive heart failure
  • abnormal kidney function
  • nd or 3rd degree AV block
  • severe bronchial asthma
  • pregnancy
  • age over 80 years
  • previously diagnosed coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turku PET Centre

Turku, 20521, Finland

Location

Turku University Hospital, Department of Medicine

Turku, 20521, Finland

Location

Related Publications (3)

  • Kajander SA, Joutsiniemi E, Saraste M, Pietila M, Ukkonen H, Saraste A, Sipila HT, Teras M, Maki M, Airaksinen J, Hartiala J, Knuuti J. Clinical value of absolute quantification of myocardial perfusion with (15)O-water in coronary artery disease. Circ Cardiovasc Imaging. 2011 Nov;4(6):678-84. doi: 10.1161/CIRCIMAGING.110.960732. Epub 2011 Sep 16.

    PMID: 21926262DERIVED

  • Bucci M, Joutsiniemi E, Saraste A, Kajander S, Ukkonen H, Saraste M, Pietila M, Sipila HT, Teras M, Maki M, Airaksinen KE, Hartiala J, Knuuti J, Iozzo P. Intrapericardial, but not extrapericardial, fat is an independent predictor of impaired hyperemic coronary perfusion in coronary artery disease. Arterioscler Thromb Vasc Biol. 2011 Jan;31(1):211-8. doi: 10.1161/ATVBAHA.110.213827. Epub 2010 Oct 28.

    PMID: 21030717DERIVED

  • Kajander S, Joutsiniemi E, Saraste M, Pietila M, Ukkonen H, Saraste A, Sipila HT, Teras M, Maki M, Airaksinen J, Hartiala J, Knuuti J. Cardiac positron emission tomography/computed tomography imaging accurately detects anatomically and functionally significant coronary artery disease. Circulation. 2010 Aug 10;122(6):603-13. doi: 10.1161/CIRCULATIONAHA.109.915009. Epub 2010 Jul 26.

    PMID: 20660808DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

January 1, 2007

Study Completion

August 1, 2008

Last Updated

August 11, 2008

Record last verified: 2008-08

Locations

FI(2)