| January 23, 2006 |
| January 9, 2009 |
| December 2005 |
| January 2008 (final data collection date for primary outcome measure) |
- Diagnostic yield: Accuracy, positive and negative predictive value. [ Time Frame: Inhospital ] [ Designated as safety issue: No ]
- pr patient evaluation [ Time Frame: Inhospital ] [ Designated as safety issue: No ]
|
- Diagnostic yield: Accuracy, positive and negative predictive value.
- pr patien evaluation
|
| Complete list of historical versions of study NCT00281346 on ClinicalTrials.gov Archive Site |
| pr stenosis evaluation [ Time Frame: Inhospital ] [ Designated as safety issue: No ] |
| pr stenosis evaluation |
| |
| Non-Invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography |
| Non-Invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography. |
Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification. |
Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded evaluation of Doppler results and coronary angiography regarding the other examination modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study.
Added January 2007 after ethics committee approval: comparison of CFVR with invasive fractional flow reserve (FFR) in selected subset of patients. |
| |
| Interventional |
| Diagnostic, Non-Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study |
- Stable Angina Pectoris
- Unstable Angina Pectoris
- Acute Myocardial Infarction
|
| Procedure: Doppler echocardiography |
| |
- Hozumi T, Yoshida K, Ogata Y, Akasaka T, Asami Y, Takagi T, Morioka S. Noninvasive assessment of significant left anterior descending coronary artery stenosis by coronary flow velocity reserve with transthoracic color Doppler echocardiography. Circulation. 1998 Apr 28;97(16):1557-62.
- Matsumura Y, Hozumi T, Watanabe H, Fujimoto K, Sugioka K, Takemoto Y, Shimada K, Muro T, Yoshiyama M, Takeuchi K, Yoshikawa J. Cut-off value of coronary flow velocity reserve by transthoracic Doppler echocardiography for diagnosis of significant left anterior descending artery stenosis in patients with coronary risk factors. Am J Cardiol. 2003 Dec 15;92(12):1389-93.
- Lethen H, P Tries H, Kersting S, Lambertz H. Validation of noninvasive assessment of coronary flow velocity reserve in the right coronary artery. A comparison of transthoracic echocardiographic results with intracoronary Doppler flow wire measurements. Eur Heart J. 2003 Sep;24(17):1567-75.
|
| |
| Completed |
| 110 |
| August 2008 |
| January 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- unstable angina or acute myocardial infarction, or stable angina pectoris and
- scheduled for coronary angiography on accepted clinical reasons
Exclusion Criteria:
- past coronary artery grafting
|
| Both |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Norway |
| |
| NCT00281346 |
| Torstein Hole, Norwegian University of Science and Technology |
| 29 FU-71-05 |
| Norwegian University of Science and Technology |
|
| Study Chair: |
Torstein L Hole, MD, PhD |
Norwegian University of Science and Technology |
|
| Principal Investigator: |
Johnny Å Vegsundvåg, MD |
Unaffiliated |
|
| Study Chair: |
Rune Wiseth, MD, PhD |
Norwegian University of Science and Technology |
|
|
| Norwegian University of Science and Technology |
| January 2009 |
