search
Back to results

Detection of Coronary Stenosis With Intravenous Microbubbles

Primary Purpose

Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optison
Definity
PESDA
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Stenosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1 Intravenous Optison Followed by Contrast Pulse Sequencing

2 Intravenous Definity followed by Contrast Pulse Sequencing

3 Intravenous PESDA followed by Contrast Pulse Sequencing

Arm Description

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

Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries

Intravenous injection of PESDA at a rate of 0.05-0.20 mL followed by Contrast Pulse Sequencing image of coronary and carotid arteries PESDA will be used exclusively in patients who are eligible for other IRB studies

Outcomes

Primary Outcome Measures

Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination

Secondary Outcome Measures

Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination
Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination

Full Information

First Posted
December 18, 2007
Last Updated
August 9, 2023
Sponsor
University of Nebraska
search

1. Study Identification

Unique Protocol Identification Number
NCT00580580
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Intravenous Optison Followed by Contrast Pulse Sequencing
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 Intravenous Definity followed by Contrast Pulse Sequencing
Arm Type
Active Comparator
Arm Description
Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries
Arm Title
3 Intravenous PESDA followed by Contrast Pulse Sequencing
Arm Type
Active Comparator
Arm Description
Intravenous injection of PESDA at a rate of 0.05-0.20 mL followed by Contrast Pulse Sequencing image of coronary and carotid arteries PESDA will be used exclusively in patients who are eligible for other IRB studies
Intervention Type
Drug
Intervention Name(s)
Optison
Intervention Description
0.1-0.4 mL through intravenous injection at the beginning of the study.
Intervention Type
Drug
Intervention Name(s)
Definity
Intervention Description
intravenous injection at 0.05-0.20 mL
Intervention Type
Drug
Intervention Name(s)
PESDA
Other Intervention Name(s)
PESDA is an investigational drug (IND 54,263)
Intervention Description
intravenous injections dosage 0.05-0.20 mL
Primary Outcome Measure Information:
Title
Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
Description
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 Measure Information:
Title
Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination
Description
Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Porter, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Detection of Coronary Stenosis With Intravenous Microbubbles

We'll reach out to this number within 24 hrs