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Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.

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ClinicalTrials.gov Identifier: NCT03646019
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Tony hayek MD, Rambam Health Care Campus

Brief Summary:
Coronary artery disease (CAD) is a major cause of death and disability in developed countries.Human studies revealed a significant association between serum oxidative status using PON1, TBARS and thiol levels and the presence of CAD and its severity. However, these studies were addressing the severity of CAD depending on coronary angiography of patients presenting with ST elevation myocardial infarction, Non ST elevation myocardial infarction, unstable angina pectoris, while part of them even had a history of CAD. Others where admitted for an elective coronary angiography for suspected stable CAD while only few patients were assessed for atypical chest pain. This study thus aims to assess the relationship between PON1 activity, TBARS and thiol levels and the existence of CAD and its severity in patients with no previous history of CAD presenting to the emergency department (ED) with acute chest pain but with no evidence of acute myocardial infarction or acute E.C.G ischemic changes. Assessment with a Cardiac CT scan instead of coronary angiography will allow the investigators to study the status of coronary atherosclerosis and calcium burden in all participants, including those presenting with atypical chest pain that most probably will not be referred by physicians to a coronary angiography. Further sub groups analysis will estimate this relationship particularly in low-intermediate risk groups depending on 3 different validated scoring systems - TIMI, GRACE and HEART score.

Condition or disease
Coronary Artery Disease Paraoxanase 1 Thiobarbituric Acid Reactive Substances Thiol Groups

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Normal coronary arteries
Non significant coronary artery disease
Significant coronary artery disease



Primary Outcome Measures :
  1. The presence and severity of coronary artery disease assessed by a cardiac CT scan / coronary angiography. [ Time Frame: 7 days ]
    The presence of coronary artery disease is defined as the presence of any atherosclerotic plaque leading to any percentage of coronary artery stenosis. The severity of coronary artery disease is defined either as significant or non significant. A Non significant coronary artery disease is defined as any coronary artery stenosis less than or equal to 49%. A Significant coronary artery disease is defined as any coronary artery stenosis more than 49%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted to the chest pain unit (CPU) in the Department of Internal Medicine E` in the Rambam Medical Health center - Israel after they presented to the ED with acute chest pain, suspected to be of cardiac origin and seems to be suitable for further investigation by a cardiac CT scan. Participants will have no previous history of CAD. E.C.G at admission is with no signs of myocardial ischemia and cardiac biomarkers are normal.
Criteria

Inclusion Criteria:

  • patients admitted to the chest pain unit (CPU) in the Department of Internal Medicine E` in the Rambam Medical Health center - Israel after they presented to the ED with acute chest pain, suspected to be of cardiac origin and seems to be suitable for further investigation by a cardiac CT scan. Participants will have no previous history of CAD. E.C.G at admission is with no signs of myocardial ischemia and cardiac biomarkers are normal.

Exclusion Criteria:

  • known CAD.
  • allergy to iodine contrast agents.
  • asthma exacerbation.
  • current use of steroids or other immunomodulating drugs.
  • renal insufficiency (creatinine level ≥ 1.5 mg/dl).
  • contraindication for radiations, as in pregnant women.
  • fever during the last 48 hours prior to admission.
  • concomitant inflammatory diseases (infections, auto immune disorders, kidney and liver diseases, and recent major surgical procedure).
  • Subjects with valvular, myocardial or pericardial diseases.
  • Poor CT image quality due to motion artifacts or inappropriate contrast delivery, resulting in non-diagnostic image quality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646019


Contacts
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Contact: Tony Hayek, professor + 972523782009 t_hayek@rambam.health.gov.il
Contact: Dima Namouz, Doctor + 972506717710 dima.namouz@gmail.com

Sponsors and Collaborators
Prof. Tony hayek MD

Additional Information:
Publications:

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Responsible Party: Prof. Tony hayek MD, Director, Department of Internal Medicine E, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03646019     History of Changes
Other Study ID Numbers: 0373-18-RMB
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Tony hayek MD, Rambam Health Care Campus:
Coronary artery disease
paraoxanase 1
Thiobarbituric Acid Reactive Substances
Thiol groups

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases