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CompletedNCT00468195BMI40Updated Mar 21, 2012

Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography

An observational study in Coronary Angiography, Obesity and Coronary Disease, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-21.

Sponsored by William Beaumont Hospitals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
175
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Obesity is one of several known risk factors to develop CAD.The CT technology has been used in a multitude of important applications around the world, and many studies have established a high accuracy in detection of specific coronary stenoses (blockages in the arteries of the heart) compared to other non-invasive modalities and invasive coronary angiography, by heart catheterization. The accuracy of coronary CT angiography (CTA) in detecting coronary disease, as compared to cardiac catheterization has been demonstrated by previous studies performed at William Beaumont Hospital. Several factors contribute to the quality of the images seen on CTA, including heart rate and respiration. Overweight and obesity are also factors that influence image quality due to a low signal to noise ratio or a "noisy image". There are no studies examining the use of various techniques to improve image quality in this high-risk population of patients.

Recent advances in multi-detector computed tomography angiography has made a noninvasive technique of diagnosis of coronary artery disease possible. Multi-detector computed tomography (MDCT) offers great promise as a risk stratification tool in patients with suspected CAD. It has been demonstrated in a multitude of accuracy studies to have a negative predictive value averaging over 95%. This leads to the hypothesis that a negative MDCT may preclude the need for invasive testing. The purpose of this study is to develop an optimal way to image obese patients without presenting an increased risk.

02

Conditions studied

  • Coronary Angiography
  • Obesity
  • Coronary Disease

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Keywords

  • tomography
  • coronary artery disease
  • obesity
03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's enrollment of 175 is below the median of 460 across 953 observational studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Body Mass Index greater than 35
  2. Age greater than 18 years
  3. Ability to provide informed consent
  4. Scheduled to undergo coronary CTA -

Exclusion criteria

Exclusion Criteria:

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

9.Known asthma or reactive airway disease.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
175 participants (actual)
06

Study locations

1 site
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00468195
Lead sponsor
William Beaumont Hospitals
Responsible party
Kavitha Chinnaiyan (Physician, William Beaumont Hospitals) — Principal investigator
First posted
May 2, 2007
Start date
May 2007
Completion
Sep 2010
Last update
Mar 21, 2012

Study contacts

Kavitha Chinnaiyan, MD
principal investigator · William Beaumont Hospitals
Gilbert Raff, MD
study director · William Beaumont Hospitals
James Goldstein, MD
study chair · William Beaumont Hospitals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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