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Recruitment Status : Withdrawn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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Carotid Stenosis Myocardial Reperfusion Drug: Optison Drug: Definity Drug: PESDA Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
Study Start Date : February 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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

 Drug: Optison
0.1-0.4 mL through intravenous injection at the beginning of the study.
Active Comparator: 2
Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries
 Drug: Definity
intravenous injection at 0.05-0.20 mL
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
 Drug: PESDA
intravenous injections dosage 0.05-0.20 mL
Other Name: PESDA is an investigational drug (IND 54,263)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination [ Time Frame: immediate ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580580


Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Layout table for investigator information
Principal Investigator: Thomas R Porter, MD University of Nebraska
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Thomas R. Porter, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00580580     History of Changes
Other Study ID Numbers: 060-03-FB
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Stenosis
Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases