Diagnosis Coronary Artery Disease Clinical Trial
— IMAGES-FFROfficial title:
Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
| Verified date | March 2015 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 83 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Inje University Ilsan Paik Hospital | Goyang | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Inje University |
Korea, Republic of,
Ahn JM, Kang SJ, Mintz GS, Oh JH, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Moon DH, Park SJ. Validation of minimal luminal area measured by intravascular ultrasound for assessment of functionally significant coronary stenosis comparison w — View Citation
Ben-Dor I, Torguson R, Gaglia MA Jr, Gonzalez MA, Maluenda G, Bui AB, Xue Z, Satler LF, Suddath WO, Lindsay J, Pichard AD, Waksman R. Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery steno — View Citation
Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 1 — View Citation
Nam CW, Yoon HJ, Cho YK, Park HS, Kim H, Hur SH, Kim YN, Chung IS, Koo BK, Tahk SJ, Fearon WF, Kim KB. Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided. JACC Cardiovasc Interv. 2010 Aug;3(8):812-7. doi: 10.1016/j.jcin.2010.04.016. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic accuracy | 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 |
1 day | No |