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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00727051
Other study ID # H9730-30837
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2007
Est. completion date July 2014

Study information

Verified date July 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States UCSF Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. Epub 2003 Dec 20. — View 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. — View Citation

Leschka S, Alkadhi H, Plass A, Desbiolles L, Grünenfelder 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. Epub 2005 Apr 19. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary patients suspected of having coronary artery disease (CAD) 1-30 days before invasive coronary angiography is performed
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