Detection of Coronary Stenosis With Intravenous Microbubbles

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging

Conditions
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Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion

Intervention / Treatment
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* Drug: Optison
* Drug: Definity
* Drug: PESDA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Intravenous Optison Followed by Contrast Pulse Sequencing<br>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<br>* 0.1-0.4 mL through intravenous injection at the beginning of the study.<br>|
| Active Comparator: 2 Intravenous Definity followed by Contrast Pulse Sequencing<br>Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries | Drug: Definity<br>* intravenous injection at 0.05-0.20 mL<br>|
| Active Comparator: 3 Intravenous PESDA followed by Contrast Pulse Sequencing<br>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 | Drug: PESDA<br>* intravenous injections dosage 0.05-0.20 mL<br>* Other names: PESDA is an investigational drug (IND 54,263);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | immediate |