Detection of Coronary Stenosis With Intravenous Microbubbles

• ClinicalTrials.gov Identifier: NCT00580580
• Recruitment Status: Withdrawn
• First Posted: December 24, 2007
• Last Update Posted: July 23, 2012
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Thomas R. Porter, MD, University of Nebraska

Tracking Information

• First Submitted Date: December 18, 2007
• First Posted Date: December 24, 2007
• Last Update Posted Date: July 23, 2012
• Study Start Date: February 2012
• Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT00580580 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Detection of Coronary Stenosis With Intravenous Microbubbles
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Coronary Stenosis
• Carotid Stenosis
• Myocardial Reperfusion

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 19, 2012): 0
• Original Estimated Enrollment (submitted: December 18, 2007): 30
• Estimated Study Completion Date: March 2014
• Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00580580
• Other Study ID Numbers: 060-03-FB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Thomas R. Porter, MD, University of Nebraska
• Study Sponsor: University of Nebraska
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thomas R Porter, MD; University of Nebraska

• PRS Account: University of Nebraska
• Verification Date: July 2012