Comparison of Two Methods to Diagnose Coronary Artery Disease

NCT00063531 | Completed

• 2 other identifiers: NA_00042276R01HL071025
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two methods of diagnosing coronary artery disease (CAD), thallium single photon emission computed tomography (SPECT) and ultrafast computed tomography (CT).

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Sensitivity of CAC vs coronary plaque volume for detecting CAD by CTA

  The question to be answered is what percentage of healthy people with a family history of early onset CAD in a sibling have only non-calcified coronary artery plaque that would not be detected by coronary calcium imaging. How much additional information is provided by CTA?

  Concurrent with CTA

Study Arms (1)

GeneSTAR participant meeting entry criteria

Healthy siblings of patients with early onset CAD (\<60 years old) and the adult offspring of the siblings or probands

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy siblings of patients with early onset CAD (\<age 60) or the adult offspring of the siblings or probands, all participants in the GeneSTAR study.

You may qualify if:

• Siblings of hospitalized index patients with documented CAD prior to 60 years of age
• Index patients who have demonstrated angiographic lesions greater than or equal to 50% in greater than or equal to 1 vessel, accompanied by angina or a documented CAD event
• Siblings with no known history of CAD
• Siblings with a positive screening test for occult CAD (abnormal ETT or thallium scan, or CAC score greater than 75th percentile) will be invited for coronary angiography

You may not qualify if:

• Index patients with CAD associated with some other primary disease (e.g., collagen vascular disease, transplantation, or chronic corticosteroid therapy)
• Siblings with a life-threatening comorbidity (e.g., AIDS, cancer)
• Siblings who have had an organ transplant
• Siblings receiving chronic glucocorticosteroids
• Siblings with known collagen vascular disease
• Siblings with a limitation that would preclude the capacity to exercise sufficiently for the test
• Siblings unable to give informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases

Study Officials

• Lewis C. Becker, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2003
• First Posted: July 1, 2003
• Study Start: June 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)