Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005696
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Early Atherosclerosis Change in Two Clinical Trials
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To complete end point analysis for the Monitored Atherosclerosis Regression Study MARS and to compare coronary versus carotid treatment effect relationships in MARS to coronary versus carotid treatment effect relationships in the Cholesterol Lowering Atherosclerosis Study CLAS Both MARS and CLAS were serial arterial imaging trials that explored the reversibility of atherosclerosis with lipid-lowering therapy in native coronary carotid and femoral arterial beds as well as in coronary artery bypass grafts
Detailed Description:
BACKGROUND
MARS was a randomized double-blind placebo-controlled angiographic trial comparing the effects of lipid lowering by lovastatin and diet with diet plus placebo in 270 subjects The target study population consisted of males and females under 70 years of age with cholesterol levels from 200 to 295 mgdL and coronary artery disease in two or more coronary artery segments Follow-up coronary angiograms were performed two and four years post-randomization in 247 and 68 subjects respectively providing information on atherosclerosis regressionprogression of coronary artery intrusive lesions Carotid ultrasound images have been recorded at four month intervals for periods up to four years in 215 subjects providing information on atherosclerosis regressionprogression of pre-intrusive intima-media thickness lesions in parallel with coronary artery intrusive lesions Unique features of MARS included 1 Simultaneous coronary angiography evaluated both by quantitative coronary angiography QCA and panel-reading and carotid ultrasonography in a cohort of over 200 subjects 2 The opportunity to evaluate the largest lipoprotein and apolipoprotein data collected in an angiographic trial to date This included extensive VLDL LDL IDL and HDL subclasses as well as LDL type pattern lipoprotein particles and apolipoprotein including AI B CIII and E and 3 The opportunity to evaluate dietary effects on atherosclerosis regressionprogression only in one other angiographic trail CLAS
The Cholesterol Lowering Atherosclerosis Study CLAS was a randomized angiographic trial comparing combined colestipolniacin therapy with placebo in 162 subjects A unique feature of MARS and CLAS has shown a similar effect in CLAS-like men non-smoking men with CABG and women Since carotid intima-media thickness QCA and global change score have been shown to be predictive of clinical coronary events understanding the relationship between these atherosclerotic measures may be important in establishing carotid intima-media thickness measurements as a proxy measure for coronary atherosclerosis
DESIGN NARRATIVE
Collected data for both trials were analyzed and compared to evaluate effects of treatment on carotid and coronary artery atherosclerotic lesions Coronary angiograms and carotid ultrasound imaging were performed under identical conditions in both trials Five major databases were available for analysis including the coronary artery database QCA processed the carotid artery database ultrasound evaluation the coronary artery database panel evaluation the nutrient content database and the clinical and biochemical database Major comparisons included measurements of atherosclerotic lesions in both arteries the effects of lipid lipoprotein and apolipoprotein levels on vascular lesions and the effect of nutrient intake in particular total fat saturated fat and cholesterol on rates of measured lesion change Additional associations were sought between preintrusive carotid lesions and intrusive coronary lesions between males and females smokers and nonsmokers differences in age and differential drug effect on HDL-cholesterol
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
MARS was a randomized double-blind placebo-controlled angiographic trial comparing the effects of lipid lowering by lovastatin and diet with diet plus placebo in 270 subjects The target study population consisted of males and females under 70 years of age with cholesterol levels from 200 to 295 mgdL and coronary artery disease in two or more coronary artery segments Follow-up coronary angiograms were performed two and four years post-randomization in 247 and 68 subjects respectively providing information on atherosclerosis regressionprogression of coronary artery intrusive lesions Carotid ultrasound images have been recorded at four month intervals for periods up to four years in 215 subjects providing information on atherosclerosis regressionprogression of pre-intrusive intima-media thickness lesions in parallel with coronary artery intrusive lesions Unique features of MARS included 1 Simultaneous coronary angiography evaluated both by quantitative coronary angiography QCA and panel-reading and carotid ultrasonography in a cohort of over 200 subjects 2 The opportunity to evaluate the largest lipoprotein and apolipoprotein data collected in an angiographic trial to date This included extensive VLDL LDL IDL and HDL subclasses as well as LDL type pattern lipoprotein particles and apolipoprotein including AI B CIII and E and 3 The opportunity to evaluate dietary effects on atherosclerosis regressionprogression only in one other angiographic trail CLAS
The Cholesterol Lowering Atherosclerosis Study CLAS was a randomized angiographic trial comparing combined colestipolniacin therapy with placebo in 162 subjects A unique feature of MARS and CLAS has shown a similar effect in CLAS-like men non-smoking men with CABG and women Since carotid intima-media thickness QCA and global change score have been shown to be predictive of clinical coronary events understanding the relationship between these atherosclerotic measures may be important in establishing carotid intima-media thickness measurements as a proxy measure for coronary atherosclerosis
DESIGN NARRATIVE
Collected data for both trials were analyzed and compared to evaluate effects of treatment on carotid and coronary artery atherosclerotic lesions Coronary angiograms and carotid ultrasound imaging were performed under identical conditions in both trials Five major databases were available for analysis including the coronary artery database QCA processed the carotid artery database ultrasound evaluation the coronary artery database panel evaluation the nutrient content database and the clinical and biochemical database Major comparisons included measurements of atherosclerotic lesions in both arteries the effects of lipid lipoprotein and apolipoprotein levels on vascular lesions and the effect of nutrient intake in particular total fat saturated fat and cholesterol on rates of measured lesion change Additional associations were sought between preintrusive carotid lesions and intrusive coronary lesions between males and females smokers and nonsmokers differences in age and differential drug effect on HDL-cholesterol
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL049885 | NIH | None | httpsreporternihgovquickSearchR01HL049885 |