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

NCT03646019 | Unknown

• 1 other identifier: 0373-18-RMB
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Paraoxanase 1; Thiobarbituric Acid Reactive Substances; Thiol Groups

Keywords

Coronary artery disease; paraoxanase 1; Thiobarbituric Acid Reactive Substances; Thiol groups

Outcome Measures

Primary Outcomes (1)

• The presence and severity of coronary artery disease assessed by a cardiac CT scan / coronary angiography.

  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%.

  7 days

Study Arms (3)

Normal coronary arteries

Non significant coronary artery disease

Significant coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Tony hayek MD: lead

Related Publications (34)

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Tony Hayek, professor

CONTACT

+ 972523782009; t_hayek@rambam.health.gov.il

Dima Namouz, Doctor

CONTACT

+ 972506717710; dima.namouz@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Internal Medicine E

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 24, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08