- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00006526
Coronary Calcification Progression Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
BACKGROUND:
While advances have been made in control of some coronary heart disease (CHD) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted CHD mortality rates has been due to medical treatment and procedural interventions for overt CHD as well as hypertension and hypercholesterolemia. In this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced CHD could allow beneficial treatments to be targeted at many high-risk individuals. The study was designed to determine whether fast-gated helical computed tomography (FGHCT), a more advanced and readily-available variant of a technique (EBCT) that has not achieved its full promise, could play such a role.
DESIGN NARRATIVE:
Dr. Crouse and his colleagues augmented ongoing case-control studies, HL35333, "Carotid Atherosclerosis Progression Study" and HL59503, "Vascular Disease, Structure and Function". HL35333 comprises 280 symptomatic individuals > 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ECIMT, with B-mode ultrasound) at baseline and yearly for three years. The grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ECIMT and its progression. HL59503 quantifies flow-mediated brachial artery reactivity (FM-BAR) in this cohort. Literature review suggests that while ECIMT predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (CLAS study) suggest that progression of ECIMT best predicted incident coronary artery disease, and Electron Beam Computed Tomography (EBCT) quantification of Coronary Artery Calcium (CAC) likely has even greater discriminatory power for coronary artery disease than ECIMT. However, EBCT has limited accessibility.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Undersøgelsestype
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Efterforskere
- John Crouse, Wake Forest University
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 951
- R01HL063264 (U.S. NIH-bevilling/kontrakt)
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