NCT00468195

Brief Summary

The purpose of this cardiovascular imaging research is to look at ways to improve the way we can look at the pictures of the heart. Patients undergo CT scans of the heart for a variety of reasons, including symptoms and/or tests suggestive of coronary artery disease (chest pain, shortness of breath, abnormal stress test, follow up exam of known/existing coronary disease, abnormal calcium score, etc.) This study involves finding ways to optimize quality of the scan in persons of size. This is because in patients with a BMI (body mass index) of greater than 40, it is usually difficult to "see" all the arteries around the heart satisfactorily. Body mass index is a number that we can get by putting your height and weight in a formula. The purpose of this study is to use a new computer software program to help us interpret your heart study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

First QC Date

April 30, 2007

Last Update Submit

March 20, 2012

Conditions

Keywords

tomographycoronary artery diseaseobesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers greater than 18 years of age; referred from EC, inpatients, physician offices

You may qualify if:

  • Body Mass Index greater than 35
  • Age greater than 18 years
  • Ability to provide informed consent
  • Scheduled to undergo coronary CTA -

You may not qualify if:

  • Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant coronary artery disease, prior coronary bypass surgery).
  • Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
  • Inability or refusal to provide informed consent.
  • Pregnancy or unknown pregnancy status.
  • Age less than 18 years.
  • Patients with known allergy to iodinated contrast.
  • \. Computed tomography imaging, or contrast administration, within the past 48 hours.
  • Known asthma or reactive airway disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

ObesityCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Kavitha Chinnaiyan, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR
  • Gilbert Raff, MD

    Corewell Health East

    STUDY DIRECTOR
  • James Goldstein, MD

    Corewell Health East

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

May 1, 2007

Study Completion

September 1, 2010

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations