Coronary StenosisNCT00580580
Detection of Coronary Stenosis With Intravenous Microbubbles
A study testing Optison, Definity and PESDA in people with Coronary Stenosis and Carotid Stenosis, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion
- What is being tested?
- Optison, Definity and PESDA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion
- Being tested
- Optison, Definity, PESDA
- Medical subject headings
- Coronary Stenosis, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptisonDrug
0.1-0.4 mL through intravenous injection at the beginning of the study.
DefinityDrug
intravenous injection at 0.05-0.20 mL
PESDADrug
Also called PESDA is an investigational drug (IND 54,263)
intravenous injections dosage 0.05-0.20 mL
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: PESDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-4 months
Secondary outcomes (1)
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
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startFeb 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580580
- Sponsor's protocol ID
- 0060-03-FB
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2007
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
- ClinicalTrials.gov ID
- NCT00580580
- Acronym / sponsor ID
- 0060-03-FB
- Conditions
- Coronary Stenosis, Carotid Stenosis, Myocardial Reperfusion
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Intravenous Optison Followed by Contrast Pulse Sequencing | Active comparator | Drug: OptisonAdministration 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 |
| 2 Intravenous Definity followed by Contrast Pulse Sequencing | Active comparator | Drug: DefinityIntravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries |
| 3 Intravenous PESDA followed by Contrast Pulse Sequencing | Active comparator | Drug: PESDAIntravenous 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optison0.1-0.4 mL through intravenous injection at the beginning of the study. | Drug | 1 Intravenous Optison Followed by Contrast Pulse Sequencing |
| Definityintravenous injection at 0.05-0.20 mL | Drug | 2 Intravenous Definity followed by Contrast Pulse Sequencing |
| PESDAAlso: PESDA is an investigational drug (IND 54,263)intravenous injections dosage 0.05-0.20 mL | Drug | 3 Intravenous PESDA followed by Contrast Pulse Sequencing |
Primary outcome
Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
Time frame: 2-4 months
To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination
1 secondary outcome
Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination
Time frame: immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Porter, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Optison, Definity and PESDA in people with Coronary Stenosis and Carotid Stenosis, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.