Cardiovascular DiseasesNCT00005696
Early Atherosclerosis Change in Two Clinical Trials
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1994to Dec 1996
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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 mg/dL 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 regression/progression 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 regression/progression 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 regression/progression only in one other angiographic trail, CLAS.
The Cholesterol Lowering Atherosclerosis Study (CLAS) was a randomized angiographic trial comparing combined colestipol/niacin 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Disease, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Disease, Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1994
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Howard Hodis, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005696
- Sponsor's protocol ID
- 4263
- Other IDs
- R01HL049885
- Status last verified
- May 2005
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Alaupovic P, Mack WJ, Knight-Gibson C, Hodis HN. The role of triglyceride-rich lipoprotein families in the progression of atherosclerotic lesions as determined by sequential coronary angiography from a controlled clinical trial. Arterioscler Thromb Vasc Biol. 1997 Apr;17(4):715-22. doi: 10.1161/01.atv.17.4.715.
PubMed 9108785Alaupovic P, Hodis HN, Knight-Gibson C, Mack WJ, LaBree L, Cashin-Hemphill L, Corder CN, Kramsch DM, Blankenhorn DH. Effects of lovastatin on ApoA- and ApoB-containing lipoproteins. Families in a subpopulation of patients participating in the Monitored Atherosclerosis Regression Study (MARS). Arterioscler Thromb. 1994 Dec;14(12):1906-13. doi: 10.1161/01.atv.14.12.1906.
PubMed 7981178Hodis HN, Mack WJ, Dunn M, Liu C, Liu C, Selzer RH, Krauss RM. Intermediate-density lipoproteins and progression of carotid arterial wall intima-media thickness. Circulation. 1997 Apr 15;95(8):2022-6. doi: 10.1161/01.cir.95.8.2022.
PubMed 9133510Markus RA, Mack WJ, Azen SP, Hodis HN. Influence of lifestyle modification on atherosclerotic progression determined by ultrasonographic change in the common carotid intima-media thickness. Am J Clin Nutr. 1997 Apr;65(4):1000-4. doi: 10.1093/ajcn/65.4.1000.
PubMed 9094885Hodis HN. Reversibility of atherosclerosis--evolving perspectives from two arterial imaging clinical trials: the cholesterol lowering atherosclerosis regression study and the monitored atherosclerosis regression study. J Cardiovasc Pharmacol. 1995;25 Suppl 4:S25-31.
PubMed 8907211Mack WJ, Hodis HN. Efficacy of interventions designed to inhibit the progression of coronary atherosclerosis. Diabetes Res Clin Pract. 1996 Feb;30 Suppl:37-53. doi: 10.1016/s0168-8227(96)80037-4.
PubMed 8964192Mack WJ, Krauss RM, Hodis HN. Lipoprotein subclasses in the Monitored Atherosclerosis Regression Study (MARS). Treatment effects and relation to coronary angiographic progression. Arterioscler Thromb Vasc Biol. 1996 May;16(5):697-704. doi: 10.1161/01.atv.16.5.697.
PubMed 8963728Hodis HN, Mack WJ, LaBree L, Selzer RH, Liu C, Liu C, Alaupovic P, Kwong-Fu H, Azen SP. Reduction in carotid arterial wall thickness using lovastatin and dietary therapy: a randomized controlled clinical trial. Ann Intern Med. 1996 Mar 15;124(6):548-56. doi: 10.7326/0003-4819-124-6-199603150-00002.
PubMed 8597317Shircore AM, Mack WJ, Selzer RH, Lee PL, Azen SP, Alaupovic P, Hodis HN. Compensatory vascular changes of remote coronary segments in response to lesion progression as observed by sequential angiography from a controlled clinical trial. Circulation. 1995 Nov 1;92(9):2411-8. doi: 10.1161/01.cir.92.9.2411.
PubMed 7586339Hodis HN, Mack WJ. Triglyceride-rich lipoproteins and the progression of coronary artery disease. Curr Opin Lipidol. 1995 Aug;6(4):209-14. doi: 10.1097/00041433-199508000-00004.
PubMed 7670749Hodis HN, Mack WJ, LaBree L, Cashin-Hemphill L, Sevanian A, Johnson R, Azen SP. Serial coronary angiographic evidence that antioxidant vitamin intake reduces progression of coronary artery atherosclerosis. JAMA. 1995 Jun 21;273(23):1849-54.
PubMed 7776501Hodis HN, Mack WJ, Azen SP, Alaupovic P, Pogoda JM, LaBree L, Hemphill LC, Kramsch DM, Blankenhorn DH. Triglyceride- and cholesterol-rich lipoproteins have a differential effect on mild/moderate and severe lesion progression as assessed by quantitative coronary angiography in a controlled trial of lovastatin. Circulation. 1994 Jul;90(1):42-9. doi: 10.1161/01.cir.90.1.42.
PubMed 8026027Mack WJ, Azen SP, Dunn M, Hodis HN. A comparison of quantitative computerized and human panel coronary endpoint measures: implications for the design of angiographic trials. Control Clin Trials. 1997 Apr;18(2):168-79. doi: 10.1016/s0197-2456(96)00181-x.
PubMed 9129860Azen SP, Qian D, Mack WJ, Sevanian A, Selzer RH, Liu CR, Liu CH, Hodis HN. Effect of supplementary antioxidant vitamin intake on carotid arterial wall intima-media thickness in a controlled clinical trial of cholesterol lowering. Circulation. 1996 Nov 15;94(10):2369-72. doi: 10.1161/01.cir.94.10.2369.
PubMed 8921775Azen SP, Mack WJ, Cashin-Hemphill L, LaBree L, Shircore AM, Selzer RH, Blankenhorn DH, Hodis HN. Progression of coronary artery disease predicts clinical coronary events. Long-term follow-up from the Cholesterol Lowering Atherosclerosis Study. Circulation. 1996 Jan 1;93(1):34-41. doi: 10.1161/01.cir.93.1.34.
PubMed 8616937
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Atherosclerosis Change in Two Clinical Trials
- ClinicalTrials.gov ID
- NCT00005696
- Acronym / sponsor ID
- 4263
- Conditions
- Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1994
- Study completion
- Dec 1996 (actual)
- First posted
- 26 May 2000 (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.
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 mg/dL 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 regression/progression 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 regression/progression 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 regression/progression only in one other angiographic trail, CLAS.
The Cholesterol Lowering Atherosclerosis Study (CLAS) was a randomized angiographic trial comparing combined colestipol/niacin 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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 29 Feb 2016.
- Background: PubMed 9108785Alaupovic P, Mack WJ, Knight-Gibson C, Hodis HN. The role of triglyceride-rich lipoprotein families in the progression of atherosclerotic lesions as determined by sequential coronary angiography from a controlled clinical trial. Arterioscler Thromb Vasc Biol. 1997 Apr;17(4):715-22. doi: 10.1161/01.atv.17.4.715.
- Background: PubMed 7981178Alaupovic P, Hodis HN, Knight-Gibson C, Mack WJ, LaBree L, Cashin-Hemphill L, Corder CN, Kramsch DM, Blankenhorn DH. Effects of lovastatin on ApoA- and ApoB-containing lipoproteins. Families in a subpopulation of patients participating in the Monitored Atherosclerosis Regression Study (MARS). Arterioscler Thromb. 1994 Dec;14(12):1906-13. doi: 10.1161/01.atv.14.12.1906.
- Background: PubMed 9133510Hodis HN, Mack WJ, Dunn M, Liu C, Liu C, Selzer RH, Krauss RM. Intermediate-density lipoproteins and progression of carotid arterial wall intima-media thickness. Circulation. 1997 Apr 15;95(8):2022-6. doi: 10.1161/01.cir.95.8.2022.
- Background: PubMed 9094885Markus RA, Mack WJ, Azen SP, Hodis HN. Influence of lifestyle modification on atherosclerotic progression determined by ultrasonographic change in the common carotid intima-media thickness. Am J Clin Nutr. 1997 Apr;65(4):1000-4. doi: 10.1093/ajcn/65.4.1000.
- Background: PubMed 8907211Hodis HN. Reversibility of atherosclerosis--evolving perspectives from two arterial imaging clinical trials: the cholesterol lowering atherosclerosis regression study and the monitored atherosclerosis regression study. J Cardiovasc Pharmacol. 1995;25 Suppl 4:S25-31.
- Background: PubMed 8964192Mack WJ, Hodis HN. Efficacy of interventions designed to inhibit the progression of coronary atherosclerosis. Diabetes Res Clin Pract. 1996 Feb;30 Suppl:37-53. doi: 10.1016/s0168-8227(96)80037-4.
- Background: PubMed 8963728Mack WJ, Krauss RM, Hodis HN. Lipoprotein subclasses in the Monitored Atherosclerosis Regression Study (MARS). Treatment effects and relation to coronary angiographic progression. Arterioscler Thromb Vasc Biol. 1996 May;16(5):697-704. doi: 10.1161/01.atv.16.5.697.
- Background: PubMed 8597317Hodis HN, Mack WJ, LaBree L, Selzer RH, Liu C, Liu C, Alaupovic P, Kwong-Fu H, Azen SP. Reduction in carotid arterial wall thickness using lovastatin and dietary therapy: a randomized controlled clinical trial. Ann Intern Med. 1996 Mar 15;124(6):548-56. doi: 10.7326/0003-4819-124-6-199603150-00002.
- Background: PubMed 7586339Shircore AM, Mack WJ, Selzer RH, Lee PL, Azen SP, Alaupovic P, Hodis HN. Compensatory vascular changes of remote coronary segments in response to lesion progression as observed by sequential angiography from a controlled clinical trial. Circulation. 1995 Nov 1;92(9):2411-8. doi: 10.1161/01.cir.92.9.2411.
- Background: PubMed 7670749Hodis HN, Mack WJ. Triglyceride-rich lipoproteins and the progression of coronary artery disease. Curr Opin Lipidol. 1995 Aug;6(4):209-14. doi: 10.1097/00041433-199508000-00004.
- Background: PubMed 7776501Hodis HN, Mack WJ, LaBree L, Cashin-Hemphill L, Sevanian A, Johnson R, Azen SP. Serial coronary angiographic evidence that antioxidant vitamin intake reduces progression of coronary artery atherosclerosis. JAMA. 1995 Jun 21;273(23):1849-54.
- Background: PubMed 8026027Hodis HN, Mack WJ, Azen SP, Alaupovic P, Pogoda JM, LaBree L, Hemphill LC, Kramsch DM, Blankenhorn DH. Triglyceride- and cholesterol-rich lipoproteins have a differential effect on mild/moderate and severe lesion progression as assessed by quantitative coronary angiography in a controlled trial of lovastatin. Circulation. 1994 Jul;90(1):42-9. doi: 10.1161/01.cir.90.1.42.
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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.
Howard Hodis
University of Southern California
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT00005696, which also lists 16 linked publications.
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 29 Feb 2016.