Coronary Artery DiseasePACENCT00670332
Prognostic Assessment of Contrast Echocardiography (PACE Study)
An observational study of Coronary Artery Disease, run by Acusphere at 1 site in United States.
Trial summary
This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 773 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to not given
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational study will enroll up to 773 patients who participated in either AI-700-32 or AI-700-33 and who were evaluated with AI-700 contrast ECHO at rest and at pharmacologic-induced stress. Approximately 28 international study centers will participate. At the time of AI-700 contrast ECHO (defined as the index date), the patients were to have had a recent history of chest pain and were to meet all eligibility criteria. Chest pain (angina) was defined as either: * typical chest pain: 1) substernal chest discomfort with a characteristic quality and duration that is 2) provoked by exertion or emotional stress and 3) relieved by rest or nitroglycerin, or * atypical chest pain (angina) that meets 2 of the 3 typical chest pain characteristics.
Eligible patients were enrolled in either AI-700-32 or AI-700-33.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography
This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO.
Read the detailed description
This observational study will investigate the ability of AI-700 contrast ECHO to predict risk of future cardiovascular events occurring in patients who had a recent history of chest pain at the time of ECHO evaluation. Eligible patients were enrolled in either AI-700-32 or AI-700-33, which are completed Phase 3 international, multicenter, open-label, dual-injection studies of the myocardial imaging capabilities and safety of AI-700 administered intravenously in patients with chest pain. In the course of these Phase 3 studies, patients were evaluated with AI-700 contrast ECHO. In addition, eligible patients were to have had an evaluable pharmacologic stress-induced AI-700 ECHO assessment as part of AI-700-32 or AI-700-33.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, echocardiography, cardiac imaging, heart disease, ultrasound contrast agent, prognosis
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).
Measured: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
Secondary outcomes (1)
Certain secondary analyses will include revascularizations and CHF.
Measured: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 773 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acusphere
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670332
- Sponsor's protocol ID
- AI-700-36
- Acronym
- PACE
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 1 May 2008
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography
- ClinicalTrials.gov ID
- NCT00670332
- Acronym / sponsor ID
- PACE / AI-700-36
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, echocardiography, cardiac imaging, heart disease, ultrasound contrast agent, prognosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 773 participants (estimated)
- Lead sponsor
- AcusphereIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- First posted
- 1 May 2008 (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.
This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO.
Detailed description
This observational study will investigate the ability of AI-700 contrast ECHO to predict risk of future cardiovascular events occurring in patients who had a recent history of chest pain at the time of ECHO evaluation. Eligible patients were enrolled in either AI-700-32 or AI-700-33, which are completed Phase 3 international, multicenter, open-label, dual-injection studies of the myocardial imaging capabilities and safety of AI-700 administered intravenously in patients with chest pain. In the course of these Phase 3 studies, patients were evaluated with AI-700 contrast ECHO. In addition, eligible patients were to have had an evaluable pharmacologic stress-induced AI-700 ECHO assessment as part of AI-700-32 or AI-700-33.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study will enroll up to 773 patients who participated in either AI-700-32 or AI-700-33 and who were evaluated with AI-700 contrast ECHO at rest and at pharmacologic-induced stress. Approximately 28 international study centers will participate. At the time of AI-700 contrast ECHO (defined as the index date), the patients were to have had a recent history of chest pain and were to meet all eligibility criteria. Chest pain (angina) was defined as either: * typical chest pain: 1) substernal chest discomfort with a characteristic quality and duration that is 2) provoked by exertion or emotional stress and 3) relieved by rest or nitroglycerin, or * atypical chest pain (angina) that meets 2 of the 3 typical chest pain characteristics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).
Time frame: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
1 secondary outcome
Certain secondary analyses will include revascularizations and CHF.
Time frame: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Acusphere at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 1 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early. Results are not available in the source record.
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?
The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI). (time frame: The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 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 1 May 2008.