Coronary Artery DiseaseNCT00727051
Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates
An observational study of Coronary Artery Disease, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver and lung transplant candidates referred for coronary angiography.
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94143
About this study
Official title: Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates.
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.
- Conditions
- Coronary Artery Disease
- Keywords
- invasive coronary angiography, multidetector coronary CTA, coronary artery disease, detecting coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Liver and lung transplant candidates referred for coronary angiography will be invited to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients suspected of having coronary artery disease (CAD)
Measured: 1-30 days before invasive coronary angiography is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen G Ordovas, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727051
- Sponsor's protocol ID
- H9730-30837
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2008
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14583357Findlay 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.
PubMed 15964381Davidson 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.
PubMed 11809445Snell 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.
PubMed 10531146Kaza 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.
PubMed 11897521Ben-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.
PubMed 16236923Herzog 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.
PubMed 14689229Leschka 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.
PubMed 15840624Raff 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.
PubMed 16053973Pannu 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.
PubMed 16714607
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates.
- ClinicalTrials.gov ID
- NCT00727051
- Acronym / sponsor ID
- H9730-30837
- Conditions
- Coronary Artery Disease
- Keywords
- invasive coronary angiography, multidetector coronary CTA, coronary artery disease, detecting coronary artery disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Liver and lung transplant candidates referred for coronary angiography will be invited to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver and lung transplant candidates referred for coronary angiography.
Key inclusion criteria (9 listed)
- Liver transplant candidates referred for invasive coronary angiography which include:
- Lung transplant candidates referred for invasive coronary angiography which include:
- Any ethnic background is acceptable.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patients suspected of having coronary artery disease (CAD)
Time frame: 1-30 days before invasive coronary angiography is performed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Background: PubMed 14583357Zoghbi 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.
- Background: PubMed 15964381Findlay 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.
- Background: PubMed 11809445Davidson 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.
- Background: PubMed 10531146Snell 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.
- Background: PubMed 11897521Kaza 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.
- Background: PubMed 16236923Ben-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.
- Background: PubMed 14689229Herzog 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.
- Background: PubMed 15840624Leschka 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.
- Background: PubMed 16053973Raff 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.
- Background: PubMed 16714607Pannu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen G Ordovas, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients suspected of having coronary artery disease (CAD) (time frame: 1-30 days before invasive coronary angiography is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727051, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.