Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01400230

Acronym

IMAGES-FFR

Enrollment

150

Registered

2011-07-22

Start date

2008-03-31

Completion date

2011-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis Coronary Artery Disease

Keywords

computed tomography, intravascular ultrasound, coronary stenosis, fractional flow reserve

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.

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.

Interventions

PROCEDUREdiagnostic 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 83 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026