Coronary AngiographyBMI40NCT00468195
Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography
An observational study of Coronary Angiography and Obesity, run by Corewell Health East at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Angiography, Obesity, Coronary Disease
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers greater than 18 years of age; referred from EC, inpatients, physician offices
Who may be able to join
- Body Mass Index greater than 35
- Age greater than 18 years
- Ability to provide informed consent
- Scheduled to undergo coronary CTA -
Who cannot join
- 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.
Show all 9Show fewer
- 8. Computed tomography imaging, or contrast administration, within the past 48 hours.
- 9.Known asthma or reactive airway disease.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Optimizing Image Quality in Obese Patients Undergoing Coronary CT Angiography
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.
- Conditions
- Coronary Angiography, Obesity, Coronary Disease
- Keywords
- tomography, coronary artery disease, obesity
- Medical subject headings
- Obesity, Coronary Disease, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startMay 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kavitha Chinnaiyan, Corewell Health East
- Investigators
- Kavitha Chinnaiyan, MD, Principal investigator, Corewell Health EastGilbert Raff, MD, Study director, Corewell Health EastJames Goldstein, MD, Study chair, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468195
- Sponsor's protocol ID
- 2007-002
- Acronym
- BMI40
- Status last verified
- Mar 2012
- First submitted
- 30 Apr 2007
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Image Quality in Obese Patients Undergoing Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT00468195
- Acronym / sponsor ID
- BMI40 / 2007-002
- Conditions
- Coronary Angiography, Obesity, Coronary Disease
- Keywords
- tomography, coronary artery disease, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Sep 2010 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers greater than 18 years of age; referred from EC, inpatients, physician offices
Key inclusion criteria (4 listed)
- Body Mass Index greater than 35
- Age greater than 18 years
- Ability to provide informed consent
- Scheduled to undergo coronary CTA -
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavitha Chinnaiyan, MD principal investigator
Corewell Health East
Gilbert Raff, MD study director
Corewell Health East
James Goldstein, MD study chair
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Angiography and Obesity, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.