Congenital DisordersNCT00266955
Retrospective of Children With ADHD and Cardiac Symptoms
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
There is some evidence suggesting ADHD medication interaction could result in mild myocardial ischemia/infarct. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: retro chart review
Who may be able to join
- ADHD
- myocardial ischemia/infarct
- no previous cardiac history
- added Straterra
- already taking Adderall
Who cannot join
- those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: A Retrospective Study of Children With ADHD and Cardiac Symptoms
There is some evidence suggesting ADHD medication interaction could result in mild myocardial ischemia/infarct.
Read the 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
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, ADHD, Adderall, Straterra
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startJan 1999
- Study completionSep 2007
Why it stopped: insufficient number of eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Martha Clabby, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266955
- Sponsor's protocol ID
- 04-111
- Status last verified
- Sep 2007
- First submitted
- 19 Dec 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Children With ADHD and Cardiac Symptoms
- ClinicalTrials.gov ID
- NCT00266955
- Acronym / sponsor ID
- 04-111
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, ADHD, Adderall, Straterra
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient number of eligible subjects
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- retro chart review
Key inclusion criteria (5 listed)
- ADHD
- myocardial ischemia/infarct
- no previous cardiac history
- added Straterra
- already taking Adderall
Key exclusion criteria (1 listed)
- those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: insufficient number of eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Clabby, MD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient number of eligible subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.