Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound

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.

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Key information

Conditions

Diagnosis Coronary Artery Disease Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–83 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

diagnostic procedures CCTA, CAG, IVUS and FFR

Procedure

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 outcomes

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)
- CCTA: % area stenosis
- IVUS: minimum lumen area
- Angiography: % diameter stenosis
Diagnostic accuracy of each parameter: (true positive+true negative)/total cases

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

Inje University

Registry information

Official study title

Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis

Acronym: IMAGES-FFR

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jul 22, 2011
Registry last updated: Mar 24, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed