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

This study has been completed.

Sponsor:

Information provided by:

University of Turku

ClinicalTrials.gov Identifier:

NCT00627172

First received: February 20, 2008

Last updated: August 8, 2008

Last verified: August 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 20, 2008
Last Updated Date	August 8, 2008
Start Date ^ICMJE	January 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 20, 2008)	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 [ Time Frame: In the beginning of the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00627172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 20, 2008)	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 [ Time Frame: In the beginning of the study ] [ Designated as safety issue: No ] Quality of life [ Time Frame: Baseline and at 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosing Coronary Artery Disease
Official Title ^ICMJE	Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosis of Coronary Artery Disease
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.
Detailed Description	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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: serum
Sampling Method	Probability Sample
Study Population	Patients with chest pain
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Kajander SA, Joutsiniemi E, Saraste M, Pietilä M, Ukkonen H, Saraste A, Sipilä HT, Teräs M, Mäki 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. Epub 2011 Sep 16. Bucci M, Joutsiniemi E, Saraste A, Kajander S, Ukkonen H, Saraste M, Pietilä M, Sipilä HT, Teräs M, Mäki 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. Epub 2010 Oct 28. Kajander S, Joutsiniemi E, Saraste M, Pietilä M, Ukkonen H, Saraste A, Sipilä HT, Teräs M, Mäki 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. Epub 2010 Jul 26.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	107
Completion Date	August 2008
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT00627172
Other Study ID Numbers ^ICMJE	15559
Has Data Monitoring Committee	No
Responsible Party	Juhani Knuuti, Director, Turku PET Centre
Study Sponsor ^ICMJE	University of Turku
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Turku
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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