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Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound (IMAGES-FFR)

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Seoul National University

Status

Completed

Conditions

Diagnosis Coronary Artery Disease

Treatments

Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR

Study type

Observational

Funder types

Other

Identifiers

NCT01400230
IB-2-1010-049

Details and patient eligibility

About

Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.

Full description

Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).

Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.

Enrollment

150 patients

Sex

All

Ages

20 to 83 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients presenting chest pain suspected stable angina or unstable angina
  • patients permit informed consents
  • patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis

Exclusion criteria

  • acute myocardial infarction
  • ejection fraction less than 40%
  • infarct related artery
  • chronic renal insufficiency
  • left main stenosis, in-stent restenosis and grafted vessels
  • allergy in contrast agent and adenosine
  • unable to get a informed consents

Trial design

150 participants in 1 patient group

CCTA-IVUS-FFR
Description:
Patients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively.
Treatment:
Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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