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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
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosis of Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

serum


Enrollment: 107
Study Start Date: January 2007
Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chest pain

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627172

Locations
Finland
Turku University Hospital, Department of Medicine
Turku, Finland, 20521
Turku PET Centre
Turku, Finland, 20521
Sponsors and Collaborators
University of Turku
  More Information

No publications provided by University of Turku

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juhani Knuuti, Director, Turku PET Centre
ClinicalTrials.gov Identifier: NCT00627172     History of Changes
Other Study ID Numbers: 15559
Study First Received: February 20, 2008
Last Updated: August 8, 2008
Health Authority: Finland: Ethics Committee

Keywords provided by University of Turku:
Coronary artery disease
MDCT
Positron emission tomography
Ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013