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

NCT00723281 | Completed DMC

• 1 other identifier: H627-29905
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Heart Transplantation; Coronary Artery Disease

Keywords

transplant coronary artery disease; CT angiography; conventional angiography; intravascular ultrasound; Heart transplant patients with known transplant coronary artery disease

Outcome Measures

Primary Outcomes (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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Roentgen Ray Society: collaborator

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (13)

• 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.

  PMID: 7594082 BACKGROUND

• 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.

  PMID: 15848715 BACKGROUND

• 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.

  PMID: 16458154 BACKGROUND

• 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.

  PMID: 15541250 BACKGROUND

• 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.

  PMID: 16904548 BACKGROUND

• 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.

  PMID: 16996866 BACKGROUND

• 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.

  PMID: 14636899 BACKGROUND

• 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.

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• 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.

  PMID: 16287217 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 7273794 BACKGROUND

• 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: 16714607 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Charles B Higgins, MD

  UCSF Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: January 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2013
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

US (1)