NCT00727051

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

7.1 years

First QC Date

July 29, 2008

Last Update Submit

July 18, 2019

Conditions

Keywords

invasive coronary angiographymultidetector coronary CTAcoronary artery diseasedetecting coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • patients suspected of having coronary artery disease (CAD)

    1-30 days before invasive coronary angiography is performed

Study Arms (1)

1

Liver and lung transplant candidates referred for coronary angiography will be invited to participate in the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver and lung transplant candidates referred for coronary angiography.

You may qualify if:

  • 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.
  • 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).
  • Any ethnic background is acceptable.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (10)

  • 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.

    PMID: 14583357BACKGROUND
  • 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.

    PMID: 15964381BACKGROUND
  • 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.

    PMID: 11809445BACKGROUND
  • 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.

    PMID: 10531146BACKGROUND
  • 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.

    PMID: 11897521BACKGROUND
  • 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.

    PMID: 16236923BACKGROUND
  • 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.

    PMID: 14689229BACKGROUND
  • 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.

    PMID: 15840624BACKGROUND
  • 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.

    PMID: 16053973BACKGROUND
  • 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.

    PMID: 16714607BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Karen G Ordovas, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

June 1, 2007

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations