Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography (BMI40)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kavitha Chinnaiyan, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00468195
First received: April 30, 2007
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition
Coronary Angiography
Obesity
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing Image Quality in Obese Patients Undergoing Coronary CT Angiography

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Enrollment: 175
Study Start Date: May 2007
Study Completion Date: September 2010
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.

  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

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

Criteria

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:

  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.

8. Computed tomography imaging, or contrast administration, within the past 48 hours.

9.Known asthma or reactive airway disease.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468195

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Kavitha Chinnaiyan, MD William Beaumont Hospitals
Study Director: Gilbert Raff, MD William Beaumont Hospitals
Study Chair: James Goldstein, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kavitha Chinnaiyan, Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00468195     History of Changes
Other Study ID Numbers: 2007-002
Study First Received: April 30, 2007
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
tomography
coronary artery disease
obesity

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Obesity
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014