Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sheba Medical Center
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01618123
First received: June 10, 2012
Last updated: July 6, 2014
Last verified: July 2014
  Purpose

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.


Condition
Myocardial Infarction
Death
Cerebrovascular Accident
Congestive Heart Failure
Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The association of EndoPat and short-term and long-term outcomes [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The comparison of different imaging modalities on short- and long-term outcomes [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618123

Contacts
Contact: Michael Shechter, MD +97235302617 Michael.Shechter@sheba.health.gov.il
Contact: Shlomi Matetzky, MD +97235302504 Shlomi.Matetzky@sheba.health.gov.il

Locations
United States, Minnesota
Mayo Clinic Chest Pain Unit, Emergency Department Not yet recruiting
Rochester, Minnesota, United States
Contact: Amir Lerman, MD       lerman.amir@mayo.edu   
Sub-Investigator: Joerg Herrman, MD         
Israel
Chest Pain Unit, Chaim Sheba Emergency Department Recruiting
Tel hashomer, Israel, 52621
Contact: Shlomi Matetzky, MD    +97235302504    Shlomi.Matetzky@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Mayo Clinic
Investigators
Principal Investigator: Michael Shechter, MD Chaim Sheba Medical Center
Principal Investigator: Shlomi Matetzky, MD Chaim Sheba Medical Center
Principal Investigator: Amir Lerman, MD Mayo Clinic
Study Director: Joerg Herman, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01618123     History of Changes
Other Study ID Numbers: SHEBA-12-9437-MS-CTIL
Study First Received: June 10, 2012
Last Updated: July 6, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Endothelial function
Coronary disease
Atherosclerosis
Chest pain

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Chest Pain
Cerebral Infarction
Stroke
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Pain
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014