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Detection of Coronary Stenosis With Intravenous Microbubbles

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00580580
First received: December 18, 2007
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging

Resource links provided by NLM:

Drug Information available for: Perflutren
U.S. FDA Resources

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 ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 Drug: Optison
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
 Drug: Definity
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
 Drug: PESDA
intravenous injections dosage 0.05-0.20 mL
Other Name: PESDA is an investigational drug (IND 54,263)

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

No publications provided

Responsible Party: Thomas R. Porter, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00580580     History of Changes
Other Study ID Numbers: 060-03-FB
Study First Received: December 18, 2007
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Coronary Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on May 16, 2013