Detection of Coronary Stenosis With Intravenous Microbubbles

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Carotid Stenosis; Coronary Stenosis; Myocardial Reperfusion
• Intervention / Treatment: Drug: Optison; Drug: Definity; Drug: PESDA

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 Intravenous Optison Followed by Contrast Pulse Sequencing; 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 Definity followed by Contrast Pulse Sequencing; 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 PESDA followed by Contrast Pulse Sequencing; Intravenous injection of PESDA at a rate of 0.05-0.20 mL followed by Contrast Pulse Sequencing 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 Names: PESDA is an investigational drug (IND 54,263)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Estimated): March 1, 2013
• Study Completion (Estimated): March 1, 2014

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimated): December 24, 2007

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: 0060-03-FB