Cardiovascular DiseasesNCT00005352
Chronic Stress as a Risk Factor in the Etiology of Coronary Heart Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. The study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1992to Aug 1996
- 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
To conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. The study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport.
Read the detailed description
DESIGN NARRATIVE:
Studies were conducted on blood pressure and the neuroendocrine effects of noise resulting from the relocation of the Munich International Airport. At the former airport site the investigators monitored people exposed to high levels of noise and then tracked these same individuals as their ambient environment became normal following the shutdown of the airport. At the new airport site, the opposite situation occurred: Individuals living in normal, quiet ambient conditions became exposed to loud aircraft noise. At both sites, control groups were formed who were not exposed to aircraft noise. The study piggybacked onto a German sponsored grant. NIH funds covered the costs of cardiovascular and psycho-physiological data analysis. Measures included biochemical assays of chronic neuroendocrine markers of stress, resting blood pressure, and reactivity of blood pressure during cognitive tasks. Perceptions of community noise levels were also assessed as possible mediators of the stressful effects of chronic exposure to ambient, environmental noise.
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
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary 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 startSep 1992
- Study completionAug 1996
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 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
- Investigators
- Gary Evans, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005352
- Sponsor's protocol ID
- 4231
- Other IDs
- R01HL047325
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Tafalla RJ, Evans GW. Noise, physiology, and human performance: the potential role of effort. J Occup Health Psychol. 1997 Apr;2(2):148-55. doi: 10.1037//1076-8998.2.2.148.
PubMed 9552287Bullinger M, Hygge S, Evans GW, Meis M, von Mackensen S. The psychological cost of aircraft noise for children. Zentralbl Hyg Umweltmed. 1999 Aug;202(2-4):127-38.
PubMed 10507123Hygge S, Evans GW, Bullinger M. A prospective study of some effects of aircraft noise on cognitive performance in schoolchildren. Psychol Sci. 2002 Sep;13(5):469-74. doi: 10.1111/1467-9280.00483.
PubMed 12219816
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Stress as a Risk Factor in the Etiology of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005352
- Acronym / sponsor ID
- 4231
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1992
- Study completion
- Aug 1996 (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 conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. The study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport.
Detailed description
DESIGN NARRATIVE:
Studies were conducted on blood pressure and the neuroendocrine effects of noise resulting from the relocation of the Munich International Airport. At the former airport site the investigators monitored people exposed to high levels of noise and then tracked these same individuals as their ambient environment became normal following the shutdown of the airport. At the new airport site, the opposite situation occurred: Individuals living in normal, quiet ambient conditions became exposed to loud aircraft noise. At both sites, control groups were formed who were not exposed to aircraft noise. The study piggybacked onto a German sponsored grant. NIH funds covered the costs of cardiovascular and psycho-physiological data analysis. Measures included biochemical assays of chronic neuroendocrine markers of stress, resting blood pressure, and reactivity of blood pressure during cognitive tasks. Perceptions of community noise levels were also assessed as possible mediators of the stressful effects of chronic exposure to ambient, environmental noise.
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 18 Feb 2016.
- Background: PubMed 9552287Tafalla RJ, Evans GW. Noise, physiology, and human performance: the potential role of effort. J Occup Health Psychol. 1997 Apr;2(2):148-55. doi: 10.1037//1076-8998.2.2.148.
- Background: PubMed 10507123Bullinger M, Hygge S, Evans GW, Meis M, von Mackensen S. The psychological cost of aircraft noise for children. Zentralbl Hyg Umweltmed. 1999 Aug;202(2-4):127-38.
- Background: PubMed 12219816Hygge S, Evans GW, Bullinger M. A prospective study of some effects of aircraft noise on cognitive performance in schoolchildren. Psychol Sci. 2002 Sep;13(5):469-74. doi: 10.1111/1467-9280.00483.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Gary Evans
Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases 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 18 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 NCT00005352, 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 18 Feb 2016.