Cardiovascular DiseasesNCT00005240
Epidemiology of Hypertensive Emergency
An observational study of Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.
Trial summary
To test the hypotheses that hypertensive emergency was associated with non-compliance with antihypertensive medication, low level of contact with the medical care system, and alcohol abuse and cigarette smoking. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1989to Dec 1992
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were enrolled in a case-control study of hypertensive emergency and urgency. Cases were patients with incidents of hypertensive emergency or hypertensive urgency, and controls were hypertensive patients with other acute conditions who were admitted to the hospital or were treated in the emergency room and released.
Who may be able to join
- 1. Patients admitted in the emergency room and for the medical and surgical services at the Presbyterian Hospital and Harlem Hospital Center in New York City
- patients with incidents of hypertensive emergency or hypertensive urgency
- hypertensive patients with other acute conditions who were admitted to the hospital or were treated in the emergency room and released
Who cannot join
- Under 21 years of age
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlates of Nonadherence to Hypertension Treatment in an Inner-City Minority Population
To test the hypotheses that hypertensive emergency was associated with non-compliance with antihypertensive medication, low level of contact with the medical care system, and alcohol abuse and cigarette smoking. Also, to describe the clinical characteristics of patients hospitalized with hypertensive emergency including morbidity, mortality, and cost, and the extent to which hypertensive emergency occured among previously diagnosed and treated hypertensives.
Read the detailed description
BACKGROUND:
While less frequent than in the era before effective treatment for hypertension, hypertensive emergency remains a relatively common cause of hospital admission in some sub-populations. In 1989, hypertensive emergency accounted for approximately 60 admissions per year to the Medical Service at Presbyterian Hospital, and a somewhat higher proportion of intensive care unit admissions and utilization. The importance of hypertensive emergency may have been underestimated because the International Classification of Diseases discharge codes included only malignant hypertension, a severe form comprising only about half of the admissions for hypertensive emergency. There had been almost no epidemiologic studies of hypertensive emergency since 1969, and very little was known about risk factors.
DESIGN NARRATIVE:
A matched case-control study design was used. Cases were obtained from admissions to the Medical Service at Presbyterian Hospital. Morbidity and mortality data were obtained by follow-up of the case series.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
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 startOct 1989
- Primary completionJun 1991
- Study completionDec 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Columbia UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Steven Shea, MD, Principal investigator, Hamilton Southworth Professor of Medicine and Professor of Epide, Dept of Medicine General Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005240
- Sponsor's protocol ID
- CUMC ID unknown (1121)
- Other IDs
- R01HL038260
- Status last verified
- Dec 2015
- First submitted
- 25 May 2000
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shea S, Misra D, Ehrlich MH, Field L, Francis CK. Correlates of nonadherence to hypertension treatment in an inner-city minority population. Am J Public Health. 1992 Dec;82(12):1607-12. doi: 10.2105/ajph.82.12.1607.
PubMed 1456334Shea S, Misra D, Ehrlich MH, Field L, Francis CK. Predisposing factors for severe, uncontrolled hypertension in an inner-city minority population. N Engl J Med. 1992 Sep 10;327(11):776-81. doi: 10.1056/NEJM199209103271107.
PubMed 1501654
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Nonadherence to Hypertension Treatment in an Inner-City Minority Population
- ClinicalTrials.gov ID
- NCT00005240
- Acronym / sponsor ID
- CUMC ID unknown (1121)
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 1989
- Primary completion
- Jun 1991 (actual)
- Study completion
- Dec 1992 (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 test the hypotheses that hypertensive emergency was associated with non-compliance with antihypertensive medication, low level of contact with the medical care system, and alcohol abuse and cigarette smoking. Also, to describe the clinical characteristics of patients hospitalized with hypertensive emergency including morbidity, mortality, and cost, and the extent to which hypertensive emergency occured among previously diagnosed and treated hypertensives.
Detailed description
BACKGROUND:
While less frequent than in the era before effective treatment for hypertension, hypertensive emergency remains a relatively common cause of hospital admission in some sub-populations. In 1989, hypertensive emergency accounted for approximately 60 admissions per year to the Medical Service at Presbyterian Hospital, and a somewhat higher proportion of intensive care unit admissions and utilization. The importance of hypertensive emergency may have been underestimated because the International Classification of Diseases discharge codes included only malignant hypertension, a severe form comprising only about half of the admissions for hypertensive emergency. There had been almost no epidemiologic studies of hypertensive emergency since 1969, and very little was known about risk factors.
DESIGN NARRATIVE:
A matched case-control study design was used. Cases were obtained from admissions to the Medical Service at Presbyterian Hospital. Morbidity and mortality data were obtained by follow-up of the case series.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were enrolled in a case-control study of hypertensive emergency and urgency. Cases were patients with incidents of hypertensive emergency or hypertensive urgency, and controls were hypertensive patients with other acute conditions who were admitted to the hospital or were treated in the emergency room and released.
Key inclusion criteria (3 listed)
- 1. Patients admitted in the emergency room and for the medical and surgical services at the Presbyterian Hospital and Harlem Hospital Center in New York City
- patients with incidents of hypertensive emergency or hypertensive urgency
- hypertensive patients with other acute conditions who were admitted to the hospital or were treated in the emergency room and released
Key exclusion criteria (2 listed)
- Under 21 years of age
- Pregnancy
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 Dec 2015.
- Background: PubMed 1456334Shea S, Misra D, Ehrlich MH, Field L, Francis CK. Correlates of nonadherence to hypertension treatment in an inner-city minority population. Am J Public Health. 1992 Dec;82(12):1607-12. doi: 10.2105/ajph.82.12.1607.
- Background: PubMed 1501654Shea S, Misra D, Ehrlich MH, Field L, Francis CK. Predisposing factors for severe, uncontrolled hypertension in an inner-city minority population. N Engl J Med. 1992 Sep 10;327(11):776-81. doi: 10.1056/NEJM199209103271107.
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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.
Steven Shea, MD principal investigator
Hamilton Southworth Professor of Medicine and Professor of Epide, Dept of Medicine General Medicine
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 Diseases and Heart Diseases, run by Columbia University 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 3 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 24 Dec 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005240, which also lists 2 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 Dec 2015.