Cardiovascular DiseaseNCT00001458
Evaluation of Patients With Heart Disease Not Eligible for Research Protocols
An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
An important mission of the National Institutes of Health (NIH) is to develop and carry out research studies designed to improve understanding of disease processes and treatments. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 7,829 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 1995to 28 Jul 2020
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects can be self-referred; referred per PCP or other specialist from any community or area of the world.@@@
Who may be able to join
- Patients with signs or symptoms or risk of cardiovascular disease may participate in this training protocol. The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:
- Coronary artery disease with effort or rest angina or inducible myocardial ischemia as determined by noninvasive testing.
- Valvular heart disease.
- Cardiomyopathies, including restrictive, congestive, and hypertrophic phenotypes.
- Peripheral-artery disease of upper or lower extremities, with intermittent pain with activity (e.g. claudication) or limb-threatening ischemia.
- Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.
- Congenital heart disease, with communications between chambers or major vessels
- Heart surgery patients treated at the Clinical Center prior to closure of the Heart Surgery Branch in 1990
Who cannot join
- Pregnancy, for those patients who require testing or treatment requiring dobutamine, gadolinium or contrast media or radiation exposure.
- Inability of patient, parent or legal guardian to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)
An important mission of the National Institutes of Health (NIH) is to develop and carry out research studies designed to improve understanding of disease processes and treatments.
Clinical research continues to become more focused on specific diseases and the signs and symptoms of diseases in specific groups of people and patients.
This study is designed to permit inpatient evaluation and care of patients with heart disease who do not qualify to participate in research studies being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI). These patients are valuable to the Cardiology Branch of the NHLBI because they help to improve training and experience of its researchers.
Read the detailed description
An important mission of the NIH is to the conduct of research that elucidates biological mechanisms, pathogenesis and treatment of diseases. Clinical research has evolved into an increasingly narrow focus on specific diseases and disease presentations in select subgroups of patients. It is desirable and consistent with Clinical Center policy, for clinical investigators to maintain exposure to a more broad spectrum of disease and disease presentations than mandated by the clinical research protocols in order to preserve clinical skills of physician and nursing staff, ensure adequate training of clinical research fellows, and stimulate ideas for future clinical research. This protocol permits evaluation and treatment of patients with cardiovascular diseases who do not fulfill eligibility criteria for participation in existing clinical research protocols, but who are of medical interest for the purpose of training professional staff.
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular Treatment, Cardiovascular Disease, Cardiovascular Testing, Heart Disease, Muscle Leg Pain, Leg Pain, Circulation, Peripheral Arterial Disease, Intermittent Claudication, Renal Vascular Disease, Uncontrolled Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular | subjects with cardiovascular symptoms or known disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
training of staff
staff becomes familiar or proficient in cardiovascular diagnostic studies.
Measured: 20 years
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 start1 Jan 1995
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,829 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alessandra Brofferio, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001458
- Sponsor's protocol ID
- 950047
- Other IDs
- 95-H-0047
- Status last verified
- Jul 2020
- First submitted
- 3 Nov 1999
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Patients With Heart and Vascular Disease (Training Protocol)
- ClinicalTrials.gov ID
- NCT00001458
- Acronym / sponsor ID
- 950047
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular Treatment, Cardiovascular Disease, Cardiovascular Testing, Heart Disease, Muscle Leg Pain, Leg Pain, Circulation, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,829 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 1 Jan 1995 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- 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.
An important mission of the National Institutes of Health (NIH) is to develop and carry out research studies designed to improve understanding of disease processes and treatments.
Clinical research continues to become more focused on specific diseases and the signs and symptoms of diseases in specific groups of people and patients.
This study is designed to permit inpatient evaluation and care of patients with heart disease who do not qualify to participate in research studies being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI). These patients are valuable to the Cardiology Branch of the NHLBI because they help to improve training and experience of its researchers.
Detailed description
An important mission of the NIH is to the conduct of research that elucidates biological mechanisms, pathogenesis and treatment of diseases. Clinical research has evolved into an increasingly narrow focus on specific diseases and disease presentations in select subgroups of patients. It is desirable and consistent with Clinical Center policy, for clinical investigators to maintain exposure to a more broad spectrum of disease and disease presentations than mandated by the clinical research protocols in order to preserve clinical skills of physician and nursing staff, ensure adequate training of clinical research fellows, and stimulate ideas for future clinical research. This protocol permits evaluation and treatment of patients with cardiovascular diseases who do not fulfill eligibility criteria for participation in existing clinical research protocols, but who are of medical interest for the purpose of training professional staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular | – | –subjects with cardiovascular symptoms or known disease. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects can be self-referred; referred per PCP or other specialist from any community or area of the world.@@@
Key inclusion criteria (8 listed)
- Patients with signs or symptoms or risk of cardiovascular disease may participate in this training protocol. The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:
- Coronary artery disease with effort or rest angina or inducible myocardial ischemia as determined by noninvasive testing.
- Valvular heart disease.
- Cardiomyopathies, including restrictive, congestive, and hypertrophic phenotypes.
- Peripheral-artery disease of upper or lower extremities, with intermittent pain with activity (e.g. claudication) or limb-threatening ischemia.
Key exclusion criteria (2 listed)
- Pregnancy, for those patients who require testing or treatment requiring dobutamine, gadolinium or contrast media or radiation exposure.
- Inability of patient, parent or legal guardian 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
training of staff
Time frame: 20 years
staff becomes familiar or proficient in cardiovascular diagnostic studies.
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 12 Mar 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Alessandra Brofferio, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
training of staff (time frame: 20 years). It is what the study was designed to measure, not a finding.
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 12 Mar 2021.