Detection of Coronary Stenosis With Intravenous Microbubbles

NCT00580580 | Withdrawn

• 1 other identifier: 0060-03-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Stenosis; Carotid Stenosis; Myocardial Reperfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination

  immediate

Study Arms (3)

1 Intravenous Optison Followed by Contrast Pulse Sequencing

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

2 Intravenous Definity followed by Contrast Pulse Sequencing

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

3 Intravenous PESDA followed by Contrast Pulse Sequencing

ACTIVE COMPARATOR

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

Interventions

Optison DRUG

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

1 Intravenous Optison Followed by Contrast Pulse Sequencing

Definity DRUG

intravenous injection at 0.05-0.20 mL

2 Intravenous Definity followed by Contrast Pulse Sequencing

PESDA DRUG

intravenous injections dosage 0.05-0.20 mL

Also known as: PESDA is an investigational drug (IND 54,263)

3 Intravenous PESDA followed by Contrast Pulse Sequencing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Coronary Stenosis; Carotid Stenosis

Interventions

FS 069; perflutren

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 23, 2024

Record last verified: 2024-09