- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618123
Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit
The Impact of Short- and Long-term Endothelial Function Assessment by Peripheral Arterial Tonometry (PAT) on Clinical Outcome in Subjects Admitted to Chest Pain Unit (CPU)
Study Overview
Status
Detailed Description
All subjects admitted to the CPU with low to moderate probability for CAD and negative troponin, will undergo the following tests upon arrival following clinical evaluation and their consenting to the study: resting ECG, EndoPAT testing and then after stress nuclear imaging or stress echocardiography. Except for EndoPAT testing, all other tests will be conducted according to the routine CPU protocol.
The results of the EndoPAT will be blinded to the treating physician until the end of the study and all patients will be managed according to the current CPU protocol, including 24-h Holter monitoring, repeat resting ECG and exercise tests (nuclear SPECT imaging or stress echocardiography, whichever is available) in addition to repeat clinical and troponin tests evaluations.
All clinical data of the recruited subjects the will be recorded and evaluated after completion of the study.
Long-term clinical follow-up All patients will be followed by telephone contact after 6 and 12 months for combined major adverse cardiovascular end-points (MACE) which include all-cause mortality, non-fatal myocardial infarction, hospitalization for heart failure or angina pectoris, stroke, coronary artery bypass grafting and percutaneous coronary interventions, by physicians who will be blinded to the patients' baseline clinical status and endothelial function (assessed by EndoPAT) results. All MACE will be validated by review of medical records by senior cardiologists blinded to the endothelial function results. In addition, on-line access to this information will facilitate verification and safe documentation of all events. In addition, written medical records will be reviewed by cardiologists in the event of any death, hospitalization and/or angina pectoris.
At the end of the study the cost effectiveness on prediction of short (in-hospital) and long (6 months, and 1 year) of EndoPAT will be assessed and will be compared to the stress tests (nuclear imaging and/or echocardiography).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Tel hashomer, Israel, 52621
- Chest Pain Unit, Chaim Sheba Emergency Department
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Chest Pain Unit, Emergency Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All subjects admitted to the CPU with low to moderate probability for CAD and negative troponin.
Exclusion Criteria:
- Subjects with chest pain and positive troponin.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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All CPU subjects
All subjects admitted to the CPU with low to moderate probability for CAD and negative troponin, will undergo the following tests upon arrival following clinical evaluation and their consenting to the study: resting ECG, EndoPAT testing and then after stress nuclear imaging or stress echocardiography.
Except for EndoPAT testing, all other tests were conducted according to the routine CPU protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The association of EndoPat and short-term and long-term outcomes
Time Frame: 1 and 2 years
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To test the hypothesis that abnormal endothelial function as assessed by EndoPAT testing will increase the prediction of the short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain unit.
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1 and 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The comparison of different imaging modalities on short- and long-term outcomes
Time Frame: 1 and 2 years
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To compare association of EndoPAT, nuclear SPECT imaging and echocardiographic stress testing on short (in-hospital) and long-term (6 months and 1 year) clinical outcome of patients with chest pain who were admitted to chest pain unit.
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1 and 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Shechter, MD, Chaim Sheba Medical Center
- Principal Investigator: Shlomi Matetzky, MD, Chaim Sheba Medical Center
- Study Director: Joerg Herman, MD, Mayo Clinic
- Principal Investigator: Amir Lerman, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Myocardial Infarction
- Infarction
- Heart Failure
- Stroke
- Chest Pain
- Angina Pectoris
Other Study ID Numbers
- SHEBA-12-9437-MS-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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