AtherosclerosisNCT00005254
Natural History of Peripheral Arterial Disease
An observational study of Atherosclerosis and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and… Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1990to Mar 1995
- 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
The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.
Read the detailed description
BACKGROUND:
Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases.
DESIGN NARRATIVE:
Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography.
Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality.
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
- Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular Diseases
- Medical subject headings
- Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular 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 1990
- Study completionMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005254
- Sponsor's protocol ID
- 1136
- Other IDs
- R01HL042973
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. doi: 10.1056/NEJM199202063260605.
PubMed 1729621Criqui MH, Langer RD, Fronek A, Feigelson HS. Coronary disease and stroke in patients with large-vessel peripheral arterial disease. Drugs. 1991;42 Suppl 5:16-21. doi: 10.2165/00003495-199100425-00005.
PubMed 1726213Feigelson HS, Criqui MH, Fronek A, Langer RD, Molgaard CA. Screening for peripheral arterial disease: the sensitivity, specificity, and predictive value of noninvasive tests in a defined population. Am J Epidemiol. 1994 Sep 15;140(6):526-34. doi: 10.1093/oxfordjournals.aje.a117279.
PubMed 8067346Long TH, Criqui MH, Vasilevskis EE, Denenberg JO, Klauber MR, Fronek A. The correlation between the severity of peripheral arterial disease and carotid occlusive disease. Vasc Med. 1999;4(3):135-42. doi: 10.1177/1358836X9900400303.
PubMed 10512592Bird CE, Criqui MH, Fronek A, Denenberg JO, Klauber MR, Langer RD. Quantitative and qualitative progression of peripheral arterial disease by non-invasive testing. Vasc Med. 1999;4(1):15-21. doi: 10.1177/1358836X9900400103.
PubMed 10355865Criqui MH, Denenberg JO, Bird CE, Fronek A, Klauber MR, Langer RD. The correlation between symptoms and non-invasive test results in patients referred for peripheral arterial disease testing. Vasc Med. 1996;1(1):65-71. doi: 10.1177/1358863X9600100112.
PubMed 9546918
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
- Natural History of Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00005254
- Acronym / sponsor ID
- 1136
- Conditions
- Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1990
- Study completion
- Mar 1995 (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.
The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.
Detailed description
BACKGROUND:
Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases.
DESIGN NARRATIVE:
Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography.
Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality.
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
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 1729621Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. doi: 10.1056/NEJM199202063260605.
- Background: PubMed 1726213Criqui MH, Langer RD, Fronek A, Feigelson HS. Coronary disease and stroke in patients with large-vessel peripheral arterial disease. Drugs. 1991;42 Suppl 5:16-21. doi: 10.2165/00003495-199100425-00005.
- Background: PubMed 8067346Feigelson HS, Criqui MH, Fronek A, Langer RD, Molgaard CA. Screening for peripheral arterial disease: the sensitivity, specificity, and predictive value of noninvasive tests in a defined population. Am J Epidemiol. 1994 Sep 15;140(6):526-34. doi: 10.1093/oxfordjournals.aje.a117279.
- Background: PubMed 10512592Long TH, Criqui MH, Vasilevskis EE, Denenberg JO, Klauber MR, Fronek A. The correlation between the severity of peripheral arterial disease and carotid occlusive disease. Vasc Med. 1999;4(3):135-42. doi: 10.1177/1358836X9900400303.
- Background: PubMed 10355865Bird CE, Criqui MH, Fronek A, Denenberg JO, Klauber MR, Langer RD. Quantitative and qualitative progression of peripheral arterial disease by non-invasive testing. Vasc Med. 1999;4(1):15-21. doi: 10.1177/1358836X9900400103.
- Background: PubMed 9546918Criqui MH, Denenberg JO, Bird CE, Fronek A, Klauber MR, Langer RD. The correlation between symptoms and non-invasive test results in patients referred for peripheral arterial disease testing. Vasc Med. 1996;1(1):65-71. doi: 10.1177/1358863X9600100112.
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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 Atherosclerosis and Coronary Disease, 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 NCT00005254, which also lists 6 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.