Clinical trial NCT01618123: Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit
Official title: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Infarction
Death
Cerebrovascular Accident
Congestive Heart Failure
Angina Pectoris
Keywords: Endothelial function
Coronary disease
Atherosclerosis
Chest pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Mayo Clinic
First posted: 2012-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: It is recognized that endothelial dysfunction is a major factor contributing to the atherogenic process. Abnormal function of the endothelium is detectable prior to obvious intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its complications. Measurement of peripheral vasodilator response with fingertip peripheral arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging as a useful method for assessing vascular function. EndoPAT may be a potential valid test increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a relatively fast non-invasive bedside test, relatively low-cost and has no side effects. Therefore, the primary objective of the study is 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The association of EndoPat and short-term and long-term outcomes
timeFrame: 1 and 2 years
Secondary outcomes:
measure: The comparison of different imaging modalities on short- and long-term outcomes
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Chest Pain Unit, Emergency Department
state: Minnesota
city: Tel hashomer
country: Israel
facility: Chest Pain Unit, Chaim Sheba Emergency Department
Study officials:
affiliation: Chaim Sheba Medical Center
name: Michael Shechter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chaim Sheba Medical Center
name: Shlomi Matetzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Joerg Herman, MD
role: STUDY_DIRECTOR
References: