Detection of Coronary Stenosis With Intravenous Microbubbles

University of Nebraska

Status: Withdrawn

Conditions: Myocardial Reperfusion; Carotid Stenosis; Coronary Stenosis

Treatments: Drug: PESDA; Drug: Definity; Drug: Optison

Study type: Interventional

Funder types: Other

Identifiers

NCT00580580

0060-03-FB

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

1 Intravenous Optison Followed by Contrast Pulse Sequencing

Active Comparator group

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

Treatment:

Drug: Optison

2 Intravenous Definity followed by Contrast Pulse Sequencing

Active Comparator group

Description:

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

Treatment:

Drug: Definity

3 Intravenous PESDA followed by Contrast Pulse Sequencing

Active Comparator group

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

Treatment:

Drug: PESDA