Prevention of Coronary Aneurysms in Kawasaki Syndrome

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Brief Title

Prevention of Coronary Aneurysms in Kawasaki Syndrome


Brief Summary

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

Detailed Description

      BACKGROUND:

      Kawasaki Syndrome is an acute febrile illness that occurs predominantly in previously healthy
      young children. It is of unknown etiology and was first described in Japan in 1967. The
      illness carries an acute mortality rate of approximately 3 percent. The Centers for Disease
      Control defines Kawasaki Syndrome as a fever lasting five or more days for which no
      explanation can be found. Patients also must have at least four of the following symptoms:
      bilateral conjunctival infection; infected or fissured lips, pharynx, or a 'strawberry
      tongue'; erythema of the palms or soles, or edema of the hands or feet, or generalized or
      periungual desquamation; rash; and cervical lymphadenopathy.

      Coronary artery aneurysms occur in 15-20 percent of children with the illness. In the past,
      no treatment had been shown to be effective in preventing this complication. Investigators in
      Japan began to use IVGG to reduce the aneurysm formation. Preliminary results showing the
      usefulness of this therapy led to a multicenter trial in Japan in which 400 mg/kg/day of IVGG
      were given for five days to children also receiving aspirin for the condition. Results of the
      Japanese trial showed that within 29 days of the onset of the disease, coronary artery
      dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of
      the IVGG and aspirin-treated children.

      DESIGN NARRATIVE:

      Phase I was randomized, unblinded and stratified by age, sex, and center. Subjects were
      randomized to receive either 80 to 120 mg/kg/day of aspirin through day 14 of illness,
      subsequently reduced to 3 to 5 mg/kg/day as a single daily dose or to 400 mg/kg/day of
      intravenous gamma globulin for four consecutive days plus aspirin as above. Primary endpoint
      was formation of aneurysms as demonstrated by echocardiograms. Follow-up was for 7 weeks.

      Phase II of the trial began enrollment of 549 patients in May 1986 and ended enrollment in
      November 1989. Two hundred and seventy six children were randomized to receive 400 mg/kg of
      intravenous gamma globulin over four consecutive days. Two hundred and seventy-three received
      a single infusion of 2 g/kg of body weight over 10 hours. Both treatment groups received 100
      mg/kg of aspirin per day through day 14 and then 3 to 5 mg/kg per day. The primary outcome
      variables were the presence or absence of coronary artery abnormalities evident at the two
      week and seven week follow-up examinations. Echocardiograms were obtained for 523 children at
      the two week visit and for 520 children at the seven week visit.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Cardiovascular Diseases

Intervention

immunoglobulins, intravenous


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

July 1985

Completion Date

November 1989


Eligibility Criteria

        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.
      

Gender

All

Ages

1 Year - 17 Years

Accepts Healthy Volunteers

No

Contacts

Fred Rosen, , 



Administrative Informations


NCT ID

NCT00000520

Organization ID

39

Secondary IDs

R01HL034545


Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)


Study Sponsor

Fred Rosen, , Children's Hospital Medical Center, Cincinnati


Verification Date

April 2012