Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging

Learn more about:
Related Clinical Trial
Clinical Precise Diagnosis and Treatment in the Kawasaki Disease A Blood Test to Diagnose Kawasaki Disease Defibrotide in Children With High Risk Kawasaki Disease Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease A Randomized Phase III Multicenter Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study) Prevention of Coronary Aneurysms in Kawasaki Syndrome A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease Anakinra and Kawasaki Disease Study of Combined Therapy of Aspirin and “IVIG-SN” in Kawasaki Disease Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease Cardiovascular Status of Children 5 Years After Kawasaki Disease Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD. A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease Etanercept in Kawasaki Disease Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease Infliximab (Remicade) for Patients With Acute Kawasaki Disease Acute Abdomen in Kawasaki Disease Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017 Different Doses of IVIG for Kawasaki Disease Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012 Measurement of Antibodies in Adults With a History of Kawasaki Disease Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease Genetic Determinants of Kawasaki Disease Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial KIDCARE (Kawasaki Disease Comparative Effectiveness Trial) Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease

Brief Title

Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging

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

Brief 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. 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.

        4. 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 Type

Observational


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.

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.

Condition

Kawasaki Disease


Study Arms / Comparison Groups

 12-50 with heart disease
Description:  12-50 with heart disease

Publications

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

Recruitment Information



Estimated Enrollment

124

Start Date

April 2009

Completion Date

March 2019

Primary Completion Date

February 2019

Eligibility Criteria

        Inclusion Criteria:• Age between 12 years and 50 years.

          -  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.

        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
      

Gender

All

Ages

12 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shelby Kutty, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00861848

Organization ID

599-08FB


Responsible Party

Sponsor

Study Sponsor

University of Nebraska


Study Sponsor

Shelby Kutty, MD, Principal Investigator, UNMC


Verification Date

March 2019