Peripheral Artery DiseaseNCT00001313
Evaluation of Patients With Known or Suspected Heart Disease
An observational study of Peripheral Artery Disease and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease, Coronary Disease, Diabetes and Heart Failure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 10 May 1992to 6 Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:
- Coronary artery disease with angina or inducible myocardial ischemia as determined by noninvasive testing.
- Cardiomyopathies including congestive phenotypes.
- Peripheral artery disease with intermittent claudication or limb-threatening ischemia.
- Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.
- Upper extremity peripheral artery disease.
- Diabetes with heart failure.
- Pulmonary hypertension.
Who cannot join
- Pregnancy, for those patients who require catheterization-based diagnostics.
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Patients With Known or Suspected Heart Disease (Screening Protocol)
In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).
Patients participating in this study will undergo a general medical evaluation, including blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform an exercise stress test.
These tests are designed to assess the types and causes of patient's heart diseases and to determine if they can participate in other, specific research studies.
Read the detailed description
The principal mission of the NIH is the conduct of research that elucidates biological mechanisms, pathogenesis, and treatment of disease. Patients with known or suspected cardiovascular diseases are referred to NHLBI cardiologists for consideration of participation in clinical research protocols. However, eligibility for participation is often uncertain from referral information or even after an outpatient evaluation. The purpose of this protocol is to permit inpatient evaluation of patients for whom participation in clinical research protocols is under consideration in order to determine protocol eligibility by means of conventional laboratory and cardiovascular testing.
- Conditions
- Peripheral Artery Disease, Coronary Disease, Diabetes and Heart Failure, Dilated Cardiomyopathy, Heart Failure, Renal Artery Stenosis
- Keywords
- Cardiac Diagnosis, Chest Pain, Hypertrophic Cardiomyopathy, Coronary Artery Disease, Microvascular Angina, Cardiac Investigation, Follow-up, Heart Disease
- Medical subject headings
- Peripheral Arterial Disease, Coronary Disease, Diabetes Mellitus, Heart Failure, Cardiomyopathy, Dilated, Renal Artery Obstruction, Hypertension, Pulmonary, Chest Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start10 May 1992
- Study completion6 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- NCT00001313
- Sponsor's protocol ID
- 920189
- Other IDs
- 92-H-0189
- Status last verified
- 6 Jan 2009
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Known or Suspected Heart Disease (Screening Protocol)
- ClinicalTrials.gov ID
- NCT00001313
- Acronym / sponsor ID
- 920189
- Conditions
- Peripheral Artery Disease, Coronary Disease, Diabetes and Heart Failure, Dilated Cardiomyopathy, Heart Failure, Renal Artery Stenosis
- Keywords
- Cardiac Diagnosis, Chest Pain, Hypertrophic Cardiomyopathy, Coronary Artery Disease, Microvascular Angina, Cardiac Investigation, Follow-up, Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 10 May 1992
- Study completion
- 6 Jan 2009
- First posted
- 4 Nov 1999 (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.
In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).
Patients participating in this study will undergo a general medical evaluation, including blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform an exercise stress test.
These tests are designed to assess the types and causes of patient's heart diseases and to determine if they can participate in other, specific research studies.
Detailed description
The principal mission of the NIH is the conduct of research that elucidates biological mechanisms, pathogenesis, and treatment of disease. Patients with known or suspected cardiovascular diseases are referred to NHLBI cardiologists for consideration of participation in clinical research protocols. However, eligibility for participation is often uncertain from referral information or even after an outpatient evaluation. The purpose of this protocol is to permit inpatient evaluation of patients for whom participation in clinical research protocols is under consideration in order to determine protocol eligibility by means of conventional laboratory and cardiovascular testing.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:
- Coronary artery disease with angina or inducible myocardial ischemia as determined by noninvasive testing.
- Cardiomyopathies including congestive phenotypes.
- Peripheral artery disease with intermittent claudication or limb-threatening ischemia.
- Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.
Key exclusion criteria (2 listed)
- Pregnancy, for those patients who require catheterization-based diagnostics.
- Inability to provide informed consent.
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 2 Jul 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 2 Jul 2017.