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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01400230
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 24, 2015
Inje University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Diagnosis Coronary Artery Disease Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR

Detailed 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.

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
Study Start Date : March 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively.
Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR
Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.
Other Names:
  • CCTA, Aquillion, Toshiba
  • IVUS, InVision Gold, Volcano and I-Lab, Boston
  • FFR, Pressure Wire, St.Jude medical

Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 1 day ]

    Evaluate and compare the diagnostic accuracy of the CCTA, IVUS and angiographic parameters for the prediction of myocardial ischemia (FFR<0.8)

    1. CCTA: % area stenosis
    2. IVUS: minimum lumen area
    3. Angiography: % diameter stenosis

    Diagnostic accuracy of each parameter: (true positive+true negative)/total cases

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Ages Eligible for Study:   20 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400230

Korea, Republic of
Inje University Ilsan Paik Hospital
Goyang, Gyeonggi-do, Korea, Republic of, 411-706
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Study Director: Joon Hyung Doh, MD, PhD Inje University
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital

Publications of Results:
Other Publications:
Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital Identifier: NCT01400230     History of Changes
Other Study ID Numbers: IB-2-1010-049
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
computed tomography
intravascular ultrasound
coronary stenosis
fractional flow reserve

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