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Completed

NCT Number: NCT00627172

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku PET Centre, Turku, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: In the beginning of the study

Secondary outcomes

  1. 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

  2. Quality of life

    Time frame: Baseline and at 1 year

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

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

Acronym: PECTUS

Important dates

Study start
2007
Study completion
2008
First posted
Feb 29, 2008
Registry last updated
Aug 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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