Coronary Artery DiseaseHERCETNCT00457379
Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study)
A study testing physical exercise in people with Coronary Artery Disease, run by Hannover Medical School at 1 site in Germany.
Trial summary
Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Apr 2008
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary artery disease
- Normal HDL-cholesterol levels in blood:
- > 40 mg/dl (1.03 mmol/L) in males
- > 50 mg/dl (1.29 mmol/L) in females
Who cannot join
- Type 1 or 2 diabetes mellitus
- Acute coronary syndrome
- Unstable angina pectoris
- Myocardial infarction during the last 8 weeks
- Therapy with niacin
- Active infections
Show all 11Show fewer
- Ventricular arrhythmias
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg
- Cancer
- Pregnant or lactating
- Alcoholism
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Ulf Landmesser, MD, +49511532 ext. 2229, Ulf.Landmesser@MH-Hannover.de
Kristina Sonnenschein, +49511532 ext. 5402, Sonnenschein.Kristina@MH-Hannover.de
About this study
Official title: Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease
Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties.
The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.
- Conditions
- Coronary Artery Disease
- Being tested
- physical exercise
- Keywords
- Coronary artery disease, HDL-Cholesterol, Endothelial Function, Endothelial Progenitor Cells, normal blood HDL-Cholesterol level
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training
Secondary outcomes (1)
flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2007
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Helmut Drexler, MD, Study director, Hannover Medical SchoolUlf Landmesser, MD, Principal investigator, Hannover Medical SchoolKristina Sonnenschein, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457379
- Sponsor's protocol ID
- 4031214
- Acronym
- HERCET
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 15 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00457379
- Acronym / sponsor ID
- HERCET / 4031214
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, HDL-Cholesterol, Endothelial Function, Endothelial Progenitor Cells, normal blood HDL-Cholesterol level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Apr 2008 (estimated)
- First posted
- 6 Apr 2007 (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.
Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties.
The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary artery disease
- Normal HDL-cholesterol levels in blood:
Key exclusion criteria (11 listed)
- Type 1 or 2 diabetes mellitus
- Acute coronary syndrome
- Unstable angina pectoris
- Myocardial infarction during the last 8 weeks
- Therapy with niacin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise | Behavioural | – |
Primary outcome
vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training
1 secondary outcome
flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2007.
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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.
Helmut Drexler, MD study director
Hannover Medical School
Ulf Landmesser, MD principal investigator
Hannover Medical School
Kristina Sonnenschein, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Coronary Artery Disease, run by Hannover Medical School at 1 site in Germany.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Aug 2007. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulf Landmesser, MD (+49511532 ext. 2229, Landmesser.Ulf@MH-Hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training. 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 15 Aug 2007.