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AzTrials

Heart TransplantationNCT00723281

Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients

An observational study of Heart Transplantation and Coronary Artery Disease, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 transplant coronary artery disease in the setting of heart transplant. Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
18 participants
Where
1 siteUnited States
Study dates
Jan 2007to Apr 2013
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All heart transplant patients at UCSF with known transplant coronary artery disease will be candidates for the study

Who may be able to join

  • Patient referred for coronary angiography and IVUS as part of their standard clinical care;
  • Patients must be 18 years of age or older.
  • 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.
  • Patients with heart rate higher than 65 bpm and contraindications for the use of beta-blockers, listed below:
  • Systolic blood pressure < 90mmHg Decompensated congestive heart failure; COPD or asthma in use of bronchodilator; Second or third degree heart block; Severe aortic stenosis, defined by a pressure gradient higher than 50 mmHg and/or the presence of symptoms.
  • Patients with contraindications for the use of nitroglycerin, listed below:
  • Severe anemia; Increased intracranial pressure; Known hypersensitivity; Use of Sildenafil Citrate (Viagra®)
  • Children and pregnant women will be excluded because of risks associated with radiation exposure.
Show all 9Show fewer
  • 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.
  • Patients with a coronary stent placed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Medical Center

    San Francisco, California, 94143

Other trials in United States

About this study

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 transplant coronary artery disease in the setting of heart transplant.

Our current protocol at UCSF for heart transplant patients involves screening with stress tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of the lumen of the coronary arteries and to assess wall thickness.

Read the detailed description

Our hypothesis is that state of the art CT coronary angiography can be used to acquire data regarding the coronary arteries in the setting of heart transplant and be used to risk stratify patients with regards to the developments of transplant coronary artery disease.

Specific Aim 1- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Specific Aim 2- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall thickness, vessel area and luminal area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Secondary Aim - To asses the correlation of cross-sectional vessel wall area, vessel wall thickness, vessel area, luminal area and vessel wall index with global and regional left ventricular function using coronary CTA.

Keywords
transplant coronary artery disease, CT angiography, conventional angiography, intravascular ultrasound, Heart transplant patients with known transplant coronary artery disease
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Based on these considerations, 18 patients will be recruited to participate in this study, including at least 10 patients with coronary allograft vasculopathy. Only CTA of patients with positive echocardiographic stress test will be included in the study

    Measured: CTA studies will be done in an interval of 1 day to 30 days before the invasive studies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionJul 2010
  4. Study completionApr 2013

Resources

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
Prospective
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723281
Sponsor's protocol ID
H627-29905
Status last verified
Jun 2019
First submitted
24 Jul 2008
Last updated
17 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Mehra MR, Ventura HO, Chambers R, Collins TJ, Ramee SR, Kates MA, Smart FW, Stapleton DD. Predictive model to assess risk for cardiac allograft vasculopathy: an intravascular ultrasound study. J Am Coll Cardiol. 1995 Nov 15;26(6):1537-44. doi: 10.1016/0735-1097(95)00357-6.

    PubMed 7594082

  • Zakliczynski M, Swierad M, Zakliczynska H, Maruszewski M, Buszman P, Zembala M. Usefulness of stanford scale of intimal hyperplasia assessed by intravascular ultrasound to predict time of onset and severity of cardiac allograft vasculopathy. Transplant Proc. 2005 Mar;37(2):1343-5. doi: 10.1016/j.transproceed.2004.12.143.

    PubMed 15848715

  • Leber AW, Becker A, Knez A, von Ziegler F, Sirol M, Nikolaou K, Ohnesorge B, Fayad ZA, Becker CR, Reiser M, Steinbeck G, Boekstegers P. Accuracy of 64-slice computed tomography to classify and quantify plaque volumes in the proximal coronary system: a comparative study using intravascular ultrasound. J Am Coll Cardiol. 2006 Feb 7;47(3):672-7. doi: 10.1016/j.jacc.2005.10.058. Epub 2006 Jan 6.

    PubMed 16458154

  • Moselewski F, Ropers D, Pohle K, Hoffmann U, Ferencik M, Chan RC, Cury RC, Abbara S, Jang IK, Brady TJ, Daniel WG, Achenbach S. Comparison of measurement of cross-sectional coronary atherosclerotic plaque and vessel areas by 16-slice multidetector computed tomography versus intravascular ultrasound. Am J Cardiol. 2004 Nov 15;94(10):1294-7. doi: 10.1016/j.amjcard.2004.07.117.

    PubMed 15541250

  • Sigurdsson G, Carrascosa P, Yamani MH, Greenberg NL, Perrone S, Lev G, Desai MY, Garcia MJ. Detection of transplant coronary artery disease using multidetector computed tomography with adaptative multisegment reconstruction. J Am Coll Cardiol. 2006 Aug 15;48(4):772-8. doi: 10.1016/j.jacc.2006.04.082. Epub 2006 Jul 25.

    PubMed 16904548

  • Gregory SA, Ferencik M, Achenbach S, Yeh RW, Hoffmann U, Inglessis I, Cury RC, Nieman K, McNulty IA, Laffan JA, Pomerantsev EV, Brady TJ, Semigran MJ, Jang IK. Comparison of sixty-four-slice multidetector computed tomographic coronary angiography to coronary angiography with intravascular ultrasound for the detection of transplant vasculopathy. Am J Cardiol. 2006 Oct 1;98(7):877-84. doi: 10.1016/j.amjcard.2006.04.027. Epub 2006 Aug 4.

    PubMed 16996866

  • Ferencik M, Moselewski F, Ropers D, Hoffmann U, Baum U, Anders K, Pomerantsev EV, Abbara S, Brady TJ, Achenbach S. Quantitative parameters of image quality in multidetector spiral computed tomographic coronary imaging with submillimeter collimation. Am J Cardiol. 2003 Dec 1;92(11):1257-62. doi: 10.1016/j.amjcard.2003.08.003.

    PubMed 14636899

  • Obuchowski NA. Estimating and comparing diagnostic tests' accuracy when the gold standard is not binary. Acad Radiol. 2005 Sep;12(9):1198-204. doi: 10.1016/j.acra.2005.05.013.

    PubMed 16099683

  • Obuchowski NA. An ROC-type measure of diagnostic accuracy when the gold standard is continuous-scale. Stat Med. 2006 Feb 15;25(3):481-93. doi: 10.1002/sim.2228.

    PubMed 16287217

  • Efron B, Tibshirani R. An Introduction to the Bootstrap. New York: Chapman and Hall; 1993

  • Kish. Survey Sampling. New York: Wiley & Sons; 1965.

  • Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.

    PubMed 7273794

  • 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.

    PubMed 16714607

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Transplantation and 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 17 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Based on these considerations, 18 patients will be recruited to participate in this study, including at least 10 patients with coronary allograft vasculopathy. Only CTA of patients with positive echocardiographic stress test will be included in the study (time frame: CTA studies will be done in an interval of 1 day to 30 days before the invasive studies). 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 NCT00723281, which also lists 13 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 17 Jun 2019.

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