Detection of Coronary Stenosis With Intravenous Microbubbles

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580580
• Other study ID #: 0060-03-FB
• Status: Withdrawn
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic
• Coronary Stenosis
• Myocardial Reperfusion

Intervention

Drug:
• Optison
0.1-0.4 mL through intravenous injection at the beginning of the study.
• Definity
intravenous injection at 0.05-0.20 mL
• PESDA
intravenous injections dosage 0.05-0.20 mL

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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