Detection of Coronary Stenosis With Intravenous Microbubbles
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
First received: December 18, 2007
Last updated: July 19, 2012
Last verified: July 2012
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
Primary Outcome Measures:
- To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Visually analyze the coronary and carotid arteries as well as perfusion defects during a standard echocardiogram examination [ Time Frame: immediate ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Active Comparator: 1
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
0.1-0.4 mL through intravenous injection at the beginning of the study.
Active Comparator: 2
Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries
intravenous injection at 0.05-0.20 mL
Active Comparator: 3
intravenous Injection of PESDA at a rate of 0.05-0.20 mL followed by image of coronary and carotid arteries PESDA will be used exclusively in patients who are eligible for other IRB studies
intravenous injections dosage 0.05-0.20 mL
Other Name: PESDA is an investigational drug (IND 54,263)
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.
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580580
|University of Nebraska Medical Center
|Omaha, Nebraska, United States, 68105 |
University of Nebraska
||Thomas R Porter, MD
||University of Nebraska
No publications provided
||Thomas R. Porter, MD, Professor, University of Nebraska
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 18, 2007
||July 19, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2015
Arterial Occlusive Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical