Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Coronary Stenosis With Intravenous Microbubbles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00580580
Recruitment Status : Withdrawn
First Posted : December 24, 2007
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 24, 2007
Last Update Posted Date July 23, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination [ Time Frame: 2-4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00580580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination [ Time Frame: immediate ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Coronary Stenosis With Intravenous Microbubbles
Official Title  ICMJE The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
Brief Summary To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.
Detailed Description The objective of this clinical study will be to visualize both coronary and carotid arteries as well as detect myocardial perfusion following a routine intravenous injection of Definity (0.05-0.20 millimeters), Optison (0.1-0.4 millimeters) or PESDA (0.05-0.2 mL). Following these injections , we will attempt to Contrast Pulse Sequencing on the Siemens Acuson Sequoia system to image both the coronary and carotid arteries, as well as the Myocardial perfusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Coronary Stenosis
  • Carotid Stenosis
  • Myocardial Reperfusion
Intervention  ICMJE
  • Drug: Optison
    0.1-0.4 mL through intravenous injection at the beginning of the study.
  • Drug: Definity
    intravenous injection at 0.05-0.20 mL
  • Drug: PESDA
    intravenous injections dosage 0.05-0.20 mL
    Other Name: PESDA is an investigational drug (IND 54,263)
Study Arms  ICMJE
  • Active Comparator: 1

    Administration of Optison (0.1-0.4 mL) intravenously followed by Contrast Pulse Sequencing to image both the coronary and carotid arteries.

    Use will depend on availability of the contrast for the given study Optison will not be used on patients with blood allergies or Jehovah Witnesses

    Intervention: Drug: Optison
  • Active Comparator: 2
    Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries
    Intervention: Drug: Definity
  • Active Comparator: 3
    intravenous Injection of PESDA at a rate of 0.05-0.20 mL followed by image of coronary and carotid arteries PESDA will be used exclusively in patients who are eligible for other IRB studies
    Intervention: Drug: PESDA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 19, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2007)
30
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subjects scheduled for routine echocardiogram to look for evidence of Coronary artery disease or a stress echocardiogram
  • women of child-bearing potential must be taking a medically approved form of birth control with a negative urine pregnancy test
  • be conscious and coherent, and be able to communicate effectively with study personnel
  • last eight patients will be diabetics who smoke
  • provide informed consent after receiving a verbal and written explanation of the purpose and nature of the study

Exclusion Criteria:

  • severe valvular heart disease by Doppler Echocardiography
  • females of child-bearing potential who are not taking a medically approved method of birth control will be excluded. If the patient is pregnant she will be excluded.
  • patients who are allergic to blood or blood products will be excluded
  • have contraindication to Optison, Definity, or PESDA (pulmonary HTN, cardiac shunt)
  • non diabetics, non smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580580
Other Study ID Numbers  ICMJE 060-03-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas R. Porter, MD, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas R Porter, MD University of Nebraska
PRS Account University of Nebraska
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP