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

This study is currently recruiting participants.
Verified December 2011 by Seoul National University Hospital
Sponsor:
Collaborator:
Inje University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01400230
First received: July 15, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Diagnosis Coronary Artery Disease
 Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 150
Study Start Date: March 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CCTA-IVUS-FFR
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400230

Contacts
Contact: Joon Hyung Doh, MD, PhD 82-10-9610-1570 joon.doh@gmail.com
Contact: Bon-Kwon Koo, MD, PhD bkkoo@snu.ac.kr

Locations
Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 411-706
Contact: Ji Ye Kim     82-31-910-7771     irb@paik.ac.kr    
Principal Investigator: Joon Hyung Doh, MD,PhD            
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Investigators
Study Director: Joon Hyung Doh, MD, PhD Inje University
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
  More Information

Publications:

Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01400230     History of Changes
Other Study ID Numbers: IB-2-1010-049
Study First Received: July 15, 2011
Last Updated: December 12, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
computed tomography
intravascular ultrasound
coronary stenosis
fractional flow reserve

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

ClinicalTrials.gov processed this record on May 16, 2013