Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- UCSF Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
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
Prazo: CTA studies will be done in an interval of 1 day to 30 days before the invasive studies
|
CTA studies will be done in an interval of 1 day to 30 days before the invasive studies
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Charles B Higgins, MD, UCSF Department of Radiology
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Efron B, Tibshirani R. An Introduction to the Bootstrap. New York: Chapman and Hall; 1993
- Kish. Survey Sampling. New York: Wiley & Sons; 1965.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H627-29905
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .