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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Withdrawn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

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

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

NCT ID

NCT00580580

First Posted

December 18, 2007

Last Updated

August 9, 2023

Sponsor

University of Nebraska

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

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

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

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

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

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Detection of Coronary Stenosis With Intravenous Microbubbles

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