The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01083134
• Other study ID #: 98-4077B
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2010
• Last updated: July 28, 2014
• Start date: March 2010
• Est. completion date: March 2020

Study information

• Verified date: June 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

With the advances in multidetector computed tomography (MDCT) technology, CT angiography (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD). Reported sensitivities and specificities of coronary CTA can compete with those of catheter angiography.

Because CT is the major source of ionizing radiation in medicine, dual isotope myocardial perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated with the highest amount of radiation dose. Recently, a new generation of MDCT machines with even more detector row (320) has become clinically available. The maximum detector width of 16 cm enables the entire heart to be examined in a single rotation and within a single heartbeat and is expected to substantially reduce artifacts from breathing and body motion. Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated examination of the heart within a single breath-hold.

The purpose of this study was to investigate the correlation of hemodynamic status of 320 MDCT, echocardiography, and coronary catheterization in patients who suspected coronary artery disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Intermediate or high risk for coronary artery disease

2. Healthy volunteers

Exclusion Criteria:

1. Unstable angina

2. Acute myocardial infarction

3. Active cancer status

4. Renal failure(Creatinine > 1.5 mg/dl)

5. Contrast allergy history

6. Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Taiwan	Cheng Gung Memorial Hospital at Linkou	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

Achenbach S, Ropers D, Kuettner A, Flohr T, Ohnesorge B, Bruder H, Theessen H, Karakaya M, Daniel WG, Bautz W, Kalender WA, Anders K. Contrast-enhanced coronary artery visualization by dual-source computed tomography--initial experience. Eur J Radiol. 2006 Mar;57(3):331-5. Epub 2006 Jan 19. — View Citation

Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. — View Citation

Einstein AJ. Radiation risk from coronary artery disease imaging: how do different diagnostic tests compare? Heart. 2008 Dec;94(12):1519-21. doi: 10.1136/hrt.2007.135731. — View Citation

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. — View Citation

Hausleiter J, Meyer T, Hadamitzky M, Huber E, Zankl M, Martinoff S, Kastrati A, Schömig A. Radiation dose estimates from cardiac multislice computed tomography in daily practice: impact of different scanning protocols on effective dose estimates. Circulation. 2006 Mar 14;113(10):1305-10. Epub 2006 Mar 6. — View Citation

Hein PA, Romano VC, Lembcke A, May J, Rogalla P. Initial experience with a chest pain protocol using 320-slice volume MDCT. Eur Radiol. 2009 May;19(5):1148-55. doi: 10.1007/s00330-008-1255-8. Epub 2009 Jan 10. — View Citation

Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation. 2006 Nov 21;114(21):2251-60. Epub 2006 Oct 30. Erratum in: Circulation. 2006 Dec 19;114(25):e651. — View Citation

Johnson TR, Nikolaou K, Wintersperger BJ, Knez A, Boekstegers P, Reiser MF, Becker CR. ECG-gated 64-MDCT angiography in the differential diagnosis of acute chest pain. AJR Am J Roentgenol. 2007 Jan;188(1):76-82. — View Citation

Scheffel H, Alkadhi H, Plass A, Vachenauer R, Desbiolles L, Gaemperli O, Schepis T, Frauenfelder T, Schertler T, Husmann L, Grunenfelder J, Genoni M, Kaufmann PA, Marincek B, Leschka S. Accuracy of dual-source CT coronary angiography: First experience in a high pre-test probability population without heart rate control. Eur Radiol. 2006 Dec;16(12):2739-47. Epub 2006 Sep 19. — View Citation

Yates SJ, Pike LC, Goldstone KE. Effect of multislice scanners on patient dose from routine CT examinations in East Anglia. Br J Radiol. 2004 Jun;77(918):472-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	No