Cardiovascular DiseasesNCT00005433
Correlates of Angiographic Changes and Coronary Events
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Southern California.
Trial summary
To examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in Atherosclerosis Study (CLAS) were used. Read more about this study
- Who is it for?
- Ages 40 to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Coronary Arteriosclerosis
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Apr 1996to Apr 1997
- 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 40 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery
Male Nonsmoker Prior coronary artery bypass graft surgery
About this study
Official title: Correlates of Angiographic Changes and Coronary Events: The Cholesterol-Lowering Atherosclerosis Study (CLAS)
To examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in Atherosclerosis Study (CLAS) were used.
Read the detailed description
BACKGROUND:
A multitude of coronary angiographic trials have been conducted using various endpoint measures based on repeated coronary angiograms. Relative to coronary event trials, angiographic trials require both a smaller sample size and reduced trial length. While such trials have assumed that angiographic endpoints are valid surrogate measures for clinical coronary events, this assumption has not been completely tested. Although several coronary angiographic endpoints are available for trial outcomes, no single method has been uniformly accepted as optimal. Because of this, the utility and validity of coronary angiographic progression for predicting future clinical coronary events remains unsettled.
The recent advent of carotid ultrasonography to assess arterial intima-media thickness (IMT) offers the exciting potential for a noninvasive measure of atherosclerosis. Because of its noninvasiveness, carotid IMTallows the extension of anti-atherosclerotic trials to both asymptomatic and frail subjects, for whom coronary angiography might be medically unethical. Because there is currently only limited support for the association of carotid IMT with clinical events or coronary atherosclerosis, the validity of carotid IMT as a potential surrogate for either endpoint has not been established.
The Cholesterol Lowering Atherosclerosis Study (CLAS) was a coronary angiographic trial testing the efficacy of colestipol-niacin therapy in 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery. Coronary artery atherosclerosis change was evaluated both by human consensus panel and by quantitative coronary angiography (QCA). In addition, B-mode ultrasounds of the common carotid artery was conducted every six months to provide measures of carotid IMT. Since the competion of the two-year CLAS study, subjects have been followed for up to 12 years. This long term follow-up of the CLAS cohort permits examination of the appropriateness of angiographic and ultrasound arterial endpoints as predictors of subsequent clinical coronary events. Angiographic and ultrasound (carotid IMT) endpoints also allow for testing of the associations between these various serial measures of atherosclerotic progression.
The results of these analyses will provide important information on the validity of these measures, which are in current use as trial endpoints, as surrogates for clinical coronary events.
DESIGN NARRATIVE:
The study used angiographic and ultrasound carotid intima medial thickness endpoints for testing the associations between these various serial measures of atherosclerotic progression and subsequent coronary heart disease.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart Diseases
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 startApr 1996
- Primary completionApr 1997
- Study completionApr 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of Southern CaliforniaThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Wendy Mack, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005433
- Sponsor's protocol ID
- 4351
- Other IDs
- R03HL054532
- Status last verified
- Apr 2017
- First submitted
- 25 May 2000
- Last updated
- 24 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodis HN, Mack WJ, LaBree L, Selzer RH, Liu CR, Liu CH, Azen SP. The role of carotid arterial intima-media thickness in predicting clinical coronary events. Ann Intern Med. 1998 Feb 15;128(4):262-9. doi: 10.7326/0003-4819-128-4-199802150-00002.
PubMed 9471928Mack WJ, LaBree L, Liu C, Selzer RH, Hodis HN. Correlations between measures of atherosclerosis change using carotid ultrasonography and coronary angiography. Atherosclerosis. 2000 Jun;150(2):371-9. doi: 10.1016/s0021-9150(99)00383-4.
PubMed 10856529Mack WJ, Xiang M, Selzer RH, Hodis HN. Serial quantitative coronary angiography and coronary events. Am Heart J. 2000 Jun;139(6):993-9. doi: 10.1067/mhj.2000.105702.
PubMed 10827379
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Angiographic Changes and Coronary Events: The Cholesterol-Lowering Atherosclerosis Study (CLAS)
- ClinicalTrials.gov ID
- NCT00005433
- Acronym / sponsor ID
- 4351
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1996
- Primary completion
- Apr 1997 (actual)
- Study completion
- Apr 1997 (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 examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in Atherosclerosis Study (CLAS) were used.
Detailed description
BACKGROUND:
A multitude of coronary angiographic trials have been conducted using various endpoint measures based on repeated coronary angiograms. Relative to coronary event trials, angiographic trials require both a smaller sample size and reduced trial length. While such trials have assumed that angiographic endpoints are valid surrogate measures for clinical coronary events, this assumption has not been completely tested. Although several coronary angiographic endpoints are available for trial outcomes, no single method has been uniformly accepted as optimal. Because of this, the utility and validity of coronary angiographic progression for predicting future clinical coronary events remains unsettled.
The recent advent of carotid ultrasonography to assess arterial intima-media thickness (IMT) offers the exciting potential for a noninvasive measure of atherosclerosis. Because of its noninvasiveness, carotid IMTallows the extension of anti-atherosclerotic trials to both asymptomatic and frail subjects, for whom coronary angiography might be medically unethical. Because there is currently only limited support for the association of carotid IMT with clinical events or coronary atherosclerosis, the validity of carotid IMT as a potential surrogate for either endpoint has not been established.
The Cholesterol Lowering Atherosclerosis Study (CLAS) was a coronary angiographic trial testing the efficacy of colestipol-niacin therapy in 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery. Coronary artery atherosclerosis change was evaluated both by human consensus panel and by quantitative coronary angiography (QCA). In addition, B-mode ultrasounds of the common carotid artery was conducted every six months to provide measures of carotid IMT. Since the competion of the two-year CLAS study, subjects have been followed for up to 12 years. This long term follow-up of the CLAS cohort permits examination of the appropriateness of angiographic and ultrasound arterial endpoints as predictors of subsequent clinical coronary events. Angiographic and ultrasound (carotid IMT) endpoints also allow for testing of the associations between these various serial measures of atherosclerotic progression.
The results of these analyses will provide important information on the validity of these measures, which are in current use as trial endpoints, as surrogates for clinical coronary events.
DESIGN NARRATIVE:
The study used angiographic and ultrasound carotid intima medial thickness endpoints for testing the associations between these various serial measures of atherosclerotic progression and subsequent coronary heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery
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 24 Apr 2017.
- Background: PubMed 9471928Hodis HN, Mack WJ, LaBree L, Selzer RH, Liu CR, Liu CH, Azen SP. The role of carotid arterial intima-media thickness in predicting clinical coronary events. Ann Intern Med. 1998 Feb 15;128(4):262-9. doi: 10.7326/0003-4819-128-4-199802150-00002.
- Background: PubMed 10856529Mack WJ, LaBree L, Liu C, Selzer RH, Hodis HN. Correlations between measures of atherosclerosis change using carotid ultrasonography and coronary angiography. Atherosclerosis. 2000 Jun;150(2):371-9. doi: 10.1016/s0021-9150(99)00383-4.
- Background: PubMed 10827379Mack WJ, Xiang M, Selzer RH, Hodis HN. Serial quantitative coronary angiography and coronary events. Am Heart J. 2000 Jun;139(6):993-9. doi: 10.1067/mhj.2000.105702.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Southern California.
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 24 Apr 2017. 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 NCT00005433, which also lists 3 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 24 Apr 2017.