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Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosing Coronary Artery Disease

NCT ID: NCT00627172

Last Updated: 2008-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Coronary MDCTA (multi-detector CT angiography) is a novel but already established and widespread diagnostic method to diagnose coronary artery disease. When performed with a 64-detector (slice) CT, its strength is an excellent negative predictive value, NPV (98%). Specificity (86%) is good but the positive predictive value (PPV) is only moderate (70%). This is due to the ability of MDCTA to detect even minor vessel wall changes before they are functionally significant, and the tendency of CT to overestimate the volume of dense calcifications. 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.

Our 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.

Conditions

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Coronary Artery Disease

Keywords

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Coronary artery disease MDCT Positron emission tomography Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* irregular rhythm
* hypersensitivity to contrast agents
* unstable chest pain
* decompensated congestive heart failure
* abnormal kidney function
* 2nd or 3rd degree AV block
* severe bronchial asthma
* pregnancy
* age over 80 years
* previously diagnosed coronary artery disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Turku PET Centre

Locations

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Turku PET Centre

Turku, , Finland

Site Status

Turku University Hospital, Department of Medicine

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 21926262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21030717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20660808 (View on PubMed)

Other Identifiers

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15559

Identifier Type: -

Identifier Source: org_study_id