Prevention of Coronary Aneurysms in Kawasaki Syndrome

NCT00000520 | Completed Phase 2

• 2 other identifiers: 39R01HL034545
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.

Conditions

Cardiovascular Diseases; Coronary Aneurysm; Heart Diseases; Mucocutaneous Lymph Node Syndrome

Interventions

immunoglobulins, intravenous DRUG

aspirin DRUG

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Boys and girls who met the CDC criteria for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (22)

• Newburger JW, Takahashi M, Burns JC, Beiser AS, Chung KJ, Duffy CE, Glode MP, Mason WH, Reddy V, Sanders SP, et al. The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med. 1986 Aug 7;315(6):341-7. doi: 10.1056/NEJM198608073150601.

  PMID: 2426590 BACKGROUND

• Burns JC, Geha RS, Schneeberger EE, Newburger JW, Rosen FS, Glezen LS, Huang AS, Natale J, Leung DY. Polymerase activity in lymphocyte culture supernatants from patients with Kawasaki disease. Nature. 1986 Oct 30-Nov 5;323(6091):814-6. doi: 10.1038/323814a0.

  PMID: 2430187 BACKGROUND

• Shulman ST, Rowley AH. Does Kawasaki disease have a retroviral aetiology? Lancet. 1986 Sep 6;2(8506):545-6. doi: 10.1016/s0140-6736(86)90115-7.

  PMID: 2427900 BACKGROUND

• Leung DY, Geha RS, Newburger JW, Burns JC, Fiers W, Lapierre LA, Pober JS. Two monokines, interleukin 1 and tumor necrosis factor, render cultured vascular endothelial cells susceptible to lysis by antibodies circulating during Kawasaki syndrome. J Exp Med. 1986 Dec 1;164(6):1958-72. doi: 10.1084/jem.164.6.1958.

  PMID: 3491174 BACKGROUND

• Burns JC, Wiggins JW Jr, Toews WH, Newburger JW, Leung DY, Wilson H, Glode MP. Clinical spectrum of Kawasaki disease in infants younger than 6 months of age. J Pediatr. 1986 Nov;109(5):759-63. doi: 10.1016/s0022-3476(86)80689-8.

  PMID: 3772656 BACKGROUND

• Gidding SS, Shulman ST, Ilbawi M, Crussi F, Duffy CE. Mucocutaneous lymph node syndrome (Kawasaki disease): delayed aortic and mitral insufficiency secondary to active valvulitis. J Am Coll Cardiol. 1986 Apr;7(4):894-7. doi: 10.1016/s0735-1097(86)80354-0.

  PMID: 3958349 BACKGROUND

• Hicks RV, Melish ME. Kawasaki syndrome. Pediatr Clin North Am. 1986 Oct;33(5):1151-75. doi: 10.1016/s0031-3955(16)36113-2.

  PMID: 3532006 BACKGROUND

• Melish ME, and Hicks RV. Kawasaki Syndrome. In: John D. Nelson (editor) Current Therapy in Pediatric Infectious Disease, pp. 106-162. The C.V. Mosby Co., 1986.

  BACKGROUND

• Takahashi M, Mason W, Lewis AB. Regression of coronary aneurysms in patients with Kawasaki syndrome. Circulation. 1987 Feb;75(2):387-94. doi: 10.1161/01.cir.75.2.387.

  PMID: 3802442 BACKGROUND

• Leung DY, Burns JC, Newburger JW, Geha RS. Reversal of lymphocyte activation in vivo in the Kawasaki syndrome by intravenous gammaglobulin. J Clin Invest. 1987 Feb;79(2):468-72. doi: 10.1172/JCI112835.

  PMID: 2433307 BACKGROUND

• Rowley AH, Gonzalez-Crussi F, Gidding SS, Duffy CE, Shulman ST. Incomplete Kawasaki disease with coronary artery involvement. Prog Clin Biol Res. 1987;250:357-65. No abstract available.

  PMID: 3423049 BACKGROUND

• Rowley AH, Shulman ST. The search for the etiology of Kawasaki disease. Pediatr Infect Dis J. 1987 Jun;6(6):506-8. doi: 10.1097/00006454-198706000-00002. No abstract available.

  PMID: 3302905 BACKGROUND

• Gidding SS, Duffy CE, Pajcic S, Berdusis K, Shulman ST. Usefulness of echocardiographic evidence of pericardial effusion and mitral regurgitation during the acute stage in predicting development of coronary arterial aneurysms in the late stage of Kawasaki disease. Am J Cardiol. 1987 Jul 1;60(1):76-9. doi: 10.1016/0002-9149(87)90988-x.

  PMID: 3604947 BACKGROUND

• Rowley AH, Shulman ST. Kawasaki disease: new etiologic clues and advances in therapy. Pediatr Dermatol. 1987 Aug;4(2):134-5. doi: 10.1111/j.1525-1470.1987.tb00767.x. No abstract available.

  PMID: 3658834 BACKGROUND

• Rowley AH, Gonzalez-Crussi F, Gidding SS, Duffy CE, Shulman ST. Incomplete Kawasaki disease with coronary artery involvement. J Pediatr. 1987 Mar;110(3):409-13. doi: 10.1016/s0022-3476(87)80503-6.

  PMID: 3819942 BACKGROUND

• Rowley AH, Shulman ST, Preble OT, Poiesz BJ, Ehrlich GD, Sullivan JR. Serum interferon concentrations and retroviral serology in Kawasaki syndrome. Pediatr Infect Dis J. 1988 Sep;7(9):663-6. No abstract available.

  PMID: 3140211 BACKGROUND

• Rowley AH, Shulman ST. What is the status of intravenous gamma-globulin for Kawasaki syndrome in the United States and Canada? Pediatr Infect Dis J. 1988 Jul;7(7):463-6. doi: 10.1097/00006454-198807000-00001. No abstract available.

  PMID: 2457202 BACKGROUND

• Rowley AH, Duffy CE, Shulman ST. Prevention of giant coronary artery aneurysms in Kawasaki disease by intravenous gamma globulin therapy. J Pediatr. 1988 Aug;113(2):290-4. doi: 10.1016/s0022-3476(88)80267-1.

  PMID: 2456378 BACKGROUND

• Leung DY, Cotran RS, Kurt-Jones E, Burns JC, Newburger JW, Pober JS. Endothelial cell activation and high interleukin-1 secretion in the pathogenesis of acute Kawasaki disease. Lancet. 1989 Dec 2;2(8675):1298-302. doi: 10.1016/s0140-6736(89)91910-7.

  PMID: 2480498 BACKGROUND

• Newburger JW, Sanders SP, Burns JC, Parness IA, Beiser AS, Colan SD. Left ventricular contractility and function in Kawasaki syndrome. Effect of intravenous gamma-globulin. Circulation. 1989 Jun;79(6):1237-46. doi: 10.1161/01.cir.79.6.1237.

  PMID: 2720925 BACKGROUND

• Burns JC, Huang AS, Newburger JW, Reinhart AL, Walsh MM, Hoch S, Leung DY. Characterization of the polymerase activity associated with cultured peripheral blood mononuclear cells from patients with Kawasaki disease. Pediatr Res. 1990 Feb;27(2):109-12. doi: 10.1203/00006450-199002000-00001.

  PMID: 1690383 BACKGROUND

• Newburger JW, Takahashi M, Beiser AS, Burns JC, Bastian J, Chung KJ, Colan SD, Duffy CE, Fulton DR, Glode MP, et al. A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome. N Engl J Med. 1991 Jun 6;324(23):1633-9. doi: 10.1056/NEJM199106063242305.

  PMID: 1709446 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Aneurysm; Heart Diseases; Mucocutaneous Lymph Node Syndrome

Interventions

Immunoglobulins, Intravenous; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Aneurysm; Vascular Diseases; Vasculitis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fred Rosen

  Children's Hospital Medical Center, Cincinnati

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: July 1, 1985
• Study Completion: November 1, 1989
• Last Updated: December 13, 2013

Record last verified: 2012-04