Retrospective of Children With ADHD and Cardiac Symptoms | NCT00266955

Studies
Retrospective of Children With ADHD and Cardiac Symptoms

NCT00266955

Sponsor

Children's Healthcare of Atlanta

Status

Terminated

Last Update Posted

Jul 6, 2011Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Congenital Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient number of eligible subjects

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Dec 19, 2005

First Submission Date that Met QC Criteria

Dec 19, 2005

First Posted Date

Dec 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Description Module

Brief Summary

There is some evidence suggesting ADHD medication interaction could result in mild myocardial ischemia/infarct.

Detailed Description

Children with no previous cardiac history who have been on Adderall for ADHD, have developed acute cardiac symptoms after the addition of Straterra for the treatment of ADHD.

We wish to do a study of the medication interactions of Straterra and other ADHD medications focusing on the cardiac manifestations.

We will collect the following information on each patient: Medical Record Number, Account number, Dates of Admission, Discharge, Treatment or Death, Information Regarding Cardiac Signs and Symptoms, Medication Information, Age, Weight, Diagnoses

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ADHD
myocardial ischemia/infarct
no previous cardiac history
added Straterra
already taking Adderall

Exclusion Criteria:

those who do not meet inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

retro chart review

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martha Clabby, MD	Children's Healthcare of Atlanta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Healthcare of Atlanta		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided