Multi-Analyte, Genetic, and Thrombogenic Markers of Atherosclerosis

NCT01276678 | Unknown

• 1 other identifier: 1478
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

About 13 million people in the United States have coronary artery disease (CAD). It is the leading cause of death in both men and women. Coronary artery disease (CAD) occurs when the blood vessels that supply blood to the heart muscle (the coronary arteries) become hardened and narrowed. The arteries harden and narrow due to buildup of fatty and calcified material called plaque on their inner walls. The buildup of plaque is also called atherosclerosis. This is a process which starts early in life, but can be influenced by multiple factors. Several factors increase the risk of developing atherosclerosis. They include high blood pressure, smoking, diabetes, high cholesterol and being related to someone who had a heart attack or a stroke. The more risk factors you have, the greater the chance that you have severe atherosclerosis. Some of the risk factors cannot be modified, like age and family history of early heart disease. The influenceable factors include high blood pressure, high blood cholesterol, high blood sugar, cigarette smoking, overweight or obesity, and lack of physical activity. Nevertheless, there are patients without any above mentioned risk factors who develop atherosclerosis. In addition to that, there are also patients with several risk factors who do not develop severe coronary artery disease. According to research studies high blood levels of some substances in the blood (biochemical markers) as well as some genes in the DNA of our cells may be associated with an increased risk of developing CAD and faster progression of the disease. The purpose of this study is to find a correlation between certain blood markers and growth of the plaques, regardless of the presence of the classic risk factors for atherosclerosis. If we prove our hypothesis we will be one step closer to predicting the extent of atherosclerosis by performing certain blood tests.

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

• severity of angiographically-defined coronary lesions as determined by comprehensive biomarker risk profile

  To develop a comprehensive biomarker risk profile that will correlate with the severity of angiographically-defined coronary lesions, independently of the classic risk factors for atherosclerosis.

  1.5 years

Secondary Outcomes (8)

• Genetic Components

  5 years

• Biomarker Profile

  1.5 years

• Drug treatment strategies

  1.5 years

• Prediction Model

  1.5 years

• Verigene

  1.5 years

Study Arms (2)

Control

300 healthy controls free from any pharmacologic therapy

Suspected CAD - Cardiac Cathetrization

subject's ≥18 years undergoing coronary angiography (inpatient cohort)or who have undergone coronary angiography within 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 1300 subject's ≥18 years undergoing coronary angiography (inpatient cohort)or who have undergone coronary angiography within 5 years (outpatient cohort, not to exceed 50 subjects) will be enrolled. In addition, 300 healthy controls free from any pharmacologic therapy will also be enrolled.

You may qualify if:

• Age ≥18 years
• Subjects scheduled for coronary angiography
• Subjects who have undergone coronary angiography within 5 years

You may not qualify if:

• Female subjects who are pregnant
• Subjects who suffer currently from an acute infection
• Subjects, who have received an experimental drug or who gave a blood donation of ≥ 1 pint within 8 weeks prior to screening
• Subjects with any coagulation, bleeding or blood disorders
• Subjects who are undergoing treatment for neoplastic diseases
• Subjects with autoimmune disease or connective tissue disease
• Subjects with HIV or hepatitis C.
• Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with the interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject

Sponsors & Collaborators

• LifeBridge Health: lead
• Accumetrics, Inc.: collaborator
• Nanosphere, Inc.: collaborator

Study Sites (1)

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

RECRUITING

Related Publications (1)

• Bliden KP, Singla A, Gesheff MG, Toth PP, Tabrizchi A, Ens G, Guyer K, Singh M, Franzese CJ, Stapleton D, Tantry US, Gurbel PA. Statin therapy and thromboxane generation in patients with coronary artery disease treated with high-dose aspirin. Thromb Haemost. 2014 Aug;112(2):323-31. doi: 10.1160/TH14-01-0094. Epub 2014 Apr 24.

  PMID: 24763965 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biomarker Analysis by Multi-Analyte Profiling Genetic Testing-GWAS and CYP2C19 genotyping Comprehensive Lipoprotein Cholesterol Profile Platelet aggregation and Thrombelastography-Clot characteristics and antiplatelet response Urinary 11-dehydrothromboxane

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul A Gurbel, M.D., FACC

  Sinai Center for Thrombosis Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin P Bliden, B.S. MBA

CONTACT

4106014795; kbliden@lifebridgehealth.org

Tania B Gesheff, MSN

CONTACT

4106014795; tgesheff@lifebridgehealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sinai Center for Thrombosis Research Program Manager

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 13, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

US (1)