Detection of Coronary Stenosis With Intravenous Microbubbles

NCT ID: NCT00580580

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-03-31

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.

Conditions

Coronary Stenosis; Carotid Stenosis; Myocardial Reperfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1 Intravenous Optison Followed by Contrast Pulse Sequencing

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

Group Type: ACTIVE_COMPARATOR

Optison

Intervention Type: DRUG

0.1-0.4 mL through intravenous injection at the beginning of the study.

2 Intravenous Definity followed by Contrast Pulse Sequencing

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

Group Type: ACTIVE_COMPARATOR

Definity

Intervention Type: DRUG

intravenous injection at 0.05-0.20 mL

3 Intravenous PESDA followed by Contrast Pulse Sequencing

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

Group Type: ACTIVE_COMPARATOR

PESDA

Intervention Type: DRUG

intravenous injections dosage 0.05-0.20 mL

Interventions

Optison

0.1-0.4 mL through intravenous injection at the beginning of the study.

Intervention Type: DRUG

Definity

intravenous injection at 0.05-0.20 mL

Intervention Type: DRUG

PESDA

intravenous injections dosage 0.05-0.20 mL

Intervention Type: DRUG

Other Intervention Names

PESDA is an investigational drug (IND 54,263)

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

0060-03-FB

Identifier Type: -

Identifier Source: org_study_id