Detection of Coronary Stenosis With Intravenous Microbubbles

Sponsor

University of Nebraska (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00580580

Collaborator

(none)

Enrollment

Location

Arms

24.9

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Stenosis Carotid Stenosis Myocardial Reperfusion	Drug: Optison Drug: Definity Drug: PESDA	N/A

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

Study Type:

Interventional

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 :

Feb 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

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 Names: PESDA is an investigational drug (IND 54,263)

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 Names:

PESDA is an investigational drug (IND 54,263)

Outcome Measures

Primary Outcome Measures

To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination [2-4 months]

Secondary Outcome Measures

Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination [immediate]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68105

Sponsors and Collaborators

University of Nebraska

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas R. Porter, MD, Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT00580580

Other Study ID Numbers:

060-03-FB

First Posted:

Dec 24, 2007

Last Update Posted:

Jul 23, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Carotid Stenosis

Coronary Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Jul 23, 2012