- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670332
Prognostic Assessment of Contrast Echocardiography (PACE Study) (PACE)
Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Watertown, Massachusetts, United States, 02472
- Acusphere
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-700-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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