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Detection of Coronary Stenosis With Intravenous Microbubbles

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00580580
Enrollment
0
Registered
2007-12-24
Start date
2012-02-29
Completion date
2014-03-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion

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.

Interventions

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

DRUGDefinity

intravenous injection at 0.05-0.20 mL

DRUGPESDA

intravenous injections dosage 0.05-0.20 mL

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination2-4 monthsTo determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination

Secondary

MeasureTime frameDescription
Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examinationimmediateVisually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026