Kawasaki DiseaseECHOBIKENCT00861848
Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging
An observational study of Kawasaki Disease and Heart Disease, run by University of Nebraska at 1 site in United States.
Trial summary
The present study is designed to: 1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 12-50 with congenital and acquired congenital heart disease 2. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease, Heart Disease
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 1 Mar 2019
- 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: ages 12-50 with congenital and acquired congenital heart disease.
Who may be able to join
- Male or female.
- History of repaired congenital heart disease including atrial septal defects, aortic valve disease, tetralogy of fallot, transposition of great arteries and anomalous left coronary artery from pulmonary artery.
- History of sequelae of heart disease acquired as an infant or child, including Kawasaki disease and coronary ectasia, and patients post anthracycline chemotherapy.
- Ability to perform Supine bicycle stress with contrast echocardiography as determined by primary cardiologist and/or Dr. Shelby Kutty.
- Ability to perform CMR with dobutamine stress as determined by the patients primary cardiologist and/or Dr. Shelby Kutty
- Signed informed consent and assent as applicable.
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- Exclusion Criteria:• Atrial or ventricular arrythmias that cannot be controlled to heart rates < 70/min
- Intracardiac shunts
- Known hypersensitivity to perflutren
- Known hypersensitivity to Dobutamine
- Congestive heart failure in NYHA class II, III or IV
- Claustrophobia or any other reason patient is unable to perform CMR (i.e. ferromagnetic implants causing significant artifact that alters image quality, presence of pacemaker, AICD, etc.)
- Pregnant or possibly pregnant (based on history/information obtained from the patient) or breast feeding
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Quantification of Ventricular Mechanics/Myocardial Blood Flow Reserve in Adolescents and Adults Ages 12-50 With Congenital or Acquired Heart Disease Using Bicycle Stress With Real Time Myocardial Contrast Echo and Dobutamine Stress MRI
The present study is designed to:
- investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 12-50 with congenital and acquired congenital heart disease
- compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion
- assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
- evaluate RV volume and function for a subset of subjects using novel reconstruction software
Read the detailed description
Individuals will be identified from the cardiology database and consented during their routine follow up visits. Exercise stress, transthoracic echocardiography and cardiac MR are part of standard medical care in the follow up evaluation of adolescents and adults with repaired congenital heart disease. The use of contrast (with transthoracic echocardiography) and dobutamine stress testing (with the cardiac MR) will be performed as part of the research study. After signing consent/ assent, a study subject will have pertinent medical history (e.g. past palliation and operative repair dates and type, current medications, review of systems) and physical exam findings extracted from the medical record, especially the recording of the most recent clinic visit. If the subject is a female of child bearing age, a serum pregnancy test will be done at this time. This data will be recorded using standardized case report forms for history and physical exam. The study patients will complete a standardized interview to determine their exercise tolerance according to New York Heart Association (NYHA) classification. All patients who consent to the additional testing will require an additional 1 hour of time to the regular Echo and CMR testing.
Each patient will have the protocol supine bicycle stress with contrast echocardiogram performed at UNMC Echo lab.. The study subject will then have the clinically indicated CMR study (Philips Achieva 1.5T magnet), scheduled and performed by a qualified CMR technologist, working with a pediatric or adult cardiologist. An attempt will be made to have CMR and Echo performed on the same day to minimize physiologic variability, but will at least be done within 1 week each other. Further post-processing (wall motion analyses, speckle tracking and myocardial tagging) and image analyses will be performed by the principal investigators on standard workstations.
- Conditions
- Kawasaki Disease, Heart Disease
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 12-50 with heart disease | 12-50 with heart disease | |
| 12-50 normal controls | 12-50 normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease.
The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease.
Measured: 2 years
Secondary outcomes (1)
Compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion (3) assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
Compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion (3) assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study start1 Apr 2009
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelby Kutty, MD, Principal investigator, UNMCThomas Porter, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861848
- Sponsor's protocol ID
- 0599-08-FB
- Acronym
- ECHOBIKE
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2009
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kutty S, Olson J, Danford CJ, Sandene EK, Xie F, Fletcher SE, Erickson CC, Kugler JD, Danford DA, Porter TR. Ultrasound contrast and real-time perfusion in conjunction with supine bicycle stress echocardiography for comprehensive evaluation of surgically corrected congenital heart disease. Eur Heart J Cardiovasc Imaging. 2012 Jun;13(6):500-9. doi: 10.1093/ejechocard/jer287. Epub 2011 Dec 15.
PubMed 22173935
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Ventricular Mechanics/Myocardial Blood Flow Reserve in Adolescents and Adults Ages 12-50 With Congenital or Acquired Heart Disease Using Bicycle Stress With Real Time Myocardial Contrast Echo and Dobutamine Stress MRI
- ClinicalTrials.gov ID
- NCT00861848
- Acronym / sponsor ID
- ECHOBIKE / 0599-08-FB
- Conditions
- Kawasaki Disease, Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Mar 2009 (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.
The present study is designed to:
- investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 12-50 with congenital and acquired congenital heart disease
- compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion
- assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
- evaluate RV volume and function for a subset of subjects using novel reconstruction software
Detailed description
Individuals will be identified from the cardiology database and consented during their routine follow up visits. Exercise stress, transthoracic echocardiography and cardiac MR are part of standard medical care in the follow up evaluation of adolescents and adults with repaired congenital heart disease. The use of contrast (with transthoracic echocardiography) and dobutamine stress testing (with the cardiac MR) will be performed as part of the research study. After signing consent/ assent, a study subject will have pertinent medical history (e.g. past palliation and operative repair dates and type, current medications, review of systems) and physical exam findings extracted from the medical record, especially the recording of the most recent clinic visit. If the subject is a female of child bearing age, a serum pregnancy test will be done at this time. This data will be recorded using standardized case report forms for history and physical exam. The study patients will complete a standardized interview to determine their exercise tolerance according to New York Heart Association (NYHA) classification. All patients who consent to the additional testing will require an additional 1 hour of time to the regular Echo and CMR testing.
Each patient will have the protocol supine bicycle stress with contrast echocardiogram performed at UNMC Echo lab.. The study subject will then have the clinically indicated CMR study (Philips Achieva 1.5T magnet), scheduled and performed by a qualified CMR technologist, working with a pediatric or adult cardiologist. An attempt will be made to have CMR and Echo performed on the same day to minimize physiologic variability, but will at least be done within 1 week each other. Further post-processing (wall motion analyses, speckle tracking and myocardial tagging) and image analyses will be performed by the principal investigators on standard workstations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-50 with heart disease | – | –12-50 with heart disease |
| 12-50 normal controls | – | –12-50 normal controls |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- ages 12-50 with congenital and acquired congenital heart disease.
Key inclusion criteria (13 listed)
- Male or female.
- History of repaired congenital heart disease including atrial septal defects, aortic valve disease, tetralogy of fallot, transposition of great arteries and anomalous left coronary artery from pulmonary artery.
- History of sequelae of heart disease acquired as an infant or child, including Kawasaki disease and coronary ectasia, and patients post anthracycline chemotherapy.
- Ability to perform Supine bicycle stress with contrast echocardiography as determined by primary cardiologist and/or Dr. Shelby Kutty.
- Ability to perform CMR with dobutamine stress as determined by the patients primary cardiologist and/or Dr. Shelby Kutty
Key exclusion criteria (0 listed)
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
The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease.
Time frame: 2 years
The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease.
1 secondary outcome
Compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion (3) assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 22173935Kutty S, Olson J, Danford CJ, Sandene EK, Xie F, Fletcher SE, Erickson CC, Kugler JD, Danford DA, Porter TR. Ultrasound contrast and real-time perfusion in conjunction with supine bicycle stress echocardiography for comprehensive evaluation of surgically corrected congenital heart disease. Eur Heart J Cardiovasc Imaging. 2012 Jun;13(6):500-9. doi: 10.1093/ejechocard/jer287. Epub 2011 Dec 15.
- Individual participant dataSharing planned: No
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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.
Shelby Kutty, MD principal investigator
UNMC
Thomas Porter, MD principal investigator
UNMC
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 Kawasaki Disease and Heart Disease, run by University of Nebraska 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 13 inclusion and 0 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: finished, as of the sponsor's last update on 25 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861848, which also lists 1 linked publication.
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 25 Sep 2023.