Multi-Analyte, Genetic, and Thrombogenic Markers of Atherosclerosis (MAGMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by LifeBridge Health
Sponsor:
Collaborators:
Accumetrics, Inc.
Nanosphere, Inc.
Information provided by (Responsible Party):
Kevin Bliden, LifeBridge Health
ClinicalTrials.gov Identifier:
NCT01276678
First received: January 11, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multi-Analyte, Genetic, and Thrombogenic Markers of Atherosclerosis (The MAGMA STUDY)

Resource links provided by NLM:


Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • severity of angiographically-defined coronary lesions as determined by comprehensive biomarker risk profile [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Genetic Components [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate the contribution of genetic components to the presence of coronary artery disease in association with environmental factors. Of interest is to see whether certain genes might accelerate atherosclerosis in subgroups like smokers, diabetics, obese subjects, or various ethnic groups

  • Biomarker Profile [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To determine the difference in the biomarker profile between CAD patients, patients with no known angiographically identified disease and healthy volunteers.

  • Drug treatment strategies [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To determine the effect of different drug treatment strategies on biomarker profile.

  • Prediction Model [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To create prediction model for major CV events based on genetic and other nongenetic biomarkers.

  • Verigene [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To demonstrate the utility of the Point-of-Care Verigene 2C19/CBS Nucleic Acid Assay for detecting CYP2C19 variants.

  • Urinary 11-dehydro thromboxane B2 [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To determine an association between urinary 11-dehydro thromboxane B2 concentrations with the severity of angiographically-defined coronary lesions.

  • Lp-PLA2 [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To determine the association between Lp-PLA2 and angiographically-defined coronary lesions.

  • Association of low-density lipoproteins/β2-glycoprotein I (β2GPI) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To determine the association between oxidized low-density lipoprotein (oxLDL)/ β2-glycoprotein I (β2GPI) complexes and angiographically-defined coronary lesions.


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


Estimated Enrollment: 1300
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT01276678

Contacts
Contact: Kevin P Bliden, B.S. MBA 4106014795 kbliden@lifebridgehealth.org
Contact: Tania B Gesheff, MSN 4106014795 tgesheff@lifebridgehealth.org

Locations
United States, Maryland
Sinai Center for Thrombosis Research Recruiting
Baltimore, Maryland, United States, 21215
Contact: Kevin P Bliden, B.S. MBA    410-601-4795    kbliden@lifebridgehealth.org   
Contact: Tania B Gesheff, MSN    4106014795    tgesheff@lifebridgehealth.org   
Sponsors and Collaborators
LifeBridge Health
Accumetrics, Inc.
Nanosphere, Inc.
Investigators
Principal Investigator: Paul A Gurbel, M.D., FACC Sinai Center for Thrombosis Research
  More Information

No publications provided

Responsible Party: Kevin Bliden, Sinai Center for Thrombosis Research Program Manager, LifeBridge Health
ClinicalTrials.gov Identifier: NCT01276678     History of Changes
Other Study ID Numbers: 1478
Study First Received: January 11, 2011
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by LifeBridge Health:
CAD

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

ClinicalTrials.gov processed this record on October 23, 2014