Clinical trial NCT00727051: Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates
Official title: Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Keywords: invasive coronary angiography
multidetector coronary CTA
coronary artery disease
detecting coronary artery disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver and lung transplant candidates referred for coronary angiography.

Brief summary: The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients prior to liver and lung transplantation. The current protocol for coronary artery disease assessment at UCSF before liver and lung transplantation involves screening with stress tests and/or coronary angiograms in patients with increased risk of coronary artery disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA accuracy.


Eligibility criteria: Inclusion Criteria:

1. Liver transplant candidates referred for invasive coronary angiography which include:

   * Patients with suspicious symptoms for CAD or;
   * Asymptomatic patients;
   * Abnormal non-invasive testing or 1 major risk factor for coronary artery disease or LVEF \< 60% on echo.
2. Lung transplant candidates referred for invasive coronary angiography which include:

   * Patients with suspicious symptoms for CAD or;
   * Asymptomatic patients;
   * Abnormal non-invasive testing or 1 major risk factor for coronary artery disease or LVEF \< 60% on echo in patients with low SVR (typical for ESLD).
3. Any ethnic background is acceptable.

Exclusion Criteria:

1. Patients with contraindications for the use of iodinated contrast (allergic reaction, renal failure, multiple myeloma, etc) will be excluded.
2. Children and pregnant women will be excluded because of risks associated with radiation exposure.
3. Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination.
4. Patients unable to give informed consent will be excluded as well.

Primary outcomes:
measure: patients suspected of having coronary artery disease (CAD)
timeFrame: 1-30 days before invasive coronary angiography is performed
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Karen G Ordovas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zoghbi GJ, Patel AD, Ershadi RE, Heo J, Bynon JS, Iskandrian AE. Usefulness of preoperative stress perfusion imaging in predicting prognosis after liver transplantation. Am J Cardiol. 2003 Nov 1;92(9):1066-71. doi: 10.1016/j.amjcard.2003.06.003.
citation: Findlay JY, Keegan MT, Pellikka PP, Rosen CB, Plevak DJ. Preoperative dobutamine stress echocardiography, intraoperative events, and intraoperative myocardial injury in liver transplantation. Transplant Proc. 2005 Jun;37(5):2209-13. doi: 10.1016/j.transproceed.2005.03.023.
citation: Davidson CJ, Gheorghiade M, Flaherty JD, Elliot MD, Reddy SP, Wang NC, Sundaram SA, Flamm SL, Blei AT, Abecassis MI, Bonow RO. Predictive value of stress myocardial perfusion imaging in liver transplant candidates. Am J Cardiol. 2002 Feb 1;89(3):359-60. doi: 10.1016/s0002-9149(01)02244-5. No abstract available.
citation: Snell GI, Richardson M, Griffiths AP, Williams TJ, Esmore DS. Coronary artery disease in potential lung transplant recipients > 50 years old: the role of coronary intervention. Chest. 1999 Oct;116(4):874-9. doi: 10.1378/chest.116.4.874.
citation: Kaza AK, Dietz JF, Kern JA, Jones DR, Robbins MK, Fiser SM, Long SM, Bergin JD, Kron IL, Tribble CG. Coronary risk stratification in patients with end-stage lung disease. J Heart Lung Transplant. 2002 Mar;21(3):334-9. doi: 10.1016/s1053-2498(01)00387-4.
citation: Ben-Dor I, Shitrit D, Kramer MR, Iakobishvili Z, Sahar G, Hasdai D. Is routine coronary angiography and revascularization indicated among patients undergoing evaluation for lung transplantation? Chest. 2005 Oct;128(4):2557-62. doi: 10.1378/chest.128.4.2557.
citation: Herzog C, Britten M, Balzer JO, Mack MG, Zangos S, Ackermann H, Schaechinger V, Schaller S, Flohr T, Vogl TJ. Multidetector-row cardiac CT: diagnostic value of calcium scoring and CT coronary angiography in patients with symptomatic, but atypical, chest pain. Eur Radiol. 2004 Feb;14(2):169-77. doi: 10.1007/s00330-003-2197-9. Epub 2003 Dec 20.
citation: Leschka S, Alkadhi H, Plass A, Desbiolles L, Grunenfelder J, Marincek B, Wildermuth S. Accuracy of MSCT coronary angiography with 64-slice technology: first experience. Eur Heart J. 2005 Aug;26(15):1482-7. doi: 10.1093/eurheartj/ehi261. Epub 2005 Apr 19.
citation: Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7. doi: 10.1016/j.jacc.2005.05.056.
citation: Pannu HK, Alvarez W Jr, Fishman EK. Beta-blockers for cardiac CT: a primer for the radiologist. AJR Am J Roentgenol. 2006 Jun;186(6 Suppl 2):S341-5. doi: 10.2214/AJR.04.1944.