Detection of Coronary Stenosis With Intravenous Microbubbles - Full Text View

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00580580

Purpose

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.

Condition	Intervention
Coronary Stenosis Carotid Stenosis Myocardial Reperfusion	Drug: Optison Drug: Definity Drug: PESDA

Drug Information available for: Octafluoropropane Albumins, human

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging

Further study details as provided by University of Nebraska:

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2003
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 0.1-0.4 mL through intravenous injection at the beginning of the study.
2: Active Comparator Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries	Drug: Definity intravenous injection at 0.05-0.20 mL
3: Active Comparator 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	Drug: PESDA intravenous injections dosage 0.05-0.20 mL

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580580

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator:

Thomas R Porter, MD

University of Nebraska

More Information

Responsible Party:	University of Nebraska Medical Center ( Thomas R Porter, Professor of Medicine )
Study ID Numbers:	060-03-FB
Study First Received:	December 18, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00580580
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Diseases
Constriction, Pathologic
Ischemia

Brain Diseases
Coronary Stenosis
Cerebrovascular Disorders
Coronary Disease
Carotid Stenosis
Carotid Artery Diseases
Coronary Artery Disease

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009