- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00468195
Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography (BMI40)
Optimizing Image Quality in Obese Patients Undergoing Coronary CT Angiography
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Michigan
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Body Mass Index greater than 35
- Age greater than 18 years
- Ability to provide informed consent
- Scheduled to undergo coronary CTA -
Exclusion Criteria:
- 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.
8. Computed tomography imaging, or contrast administration, within the past 48 hours.
9.Known asthma or reactive airway disease.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kavitha Chinnaiyan, MD, William Beaumont Hospitals
- Studieleder: Gilbert Raff, MD, William Beaumont Hospitals
- Studiestol: James Goldstein, MD, William Beaumont Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007-002
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Kliniske forsøg med Koronar sygdom
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IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien