NCT00457379

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 15, 2007

Status Verified

April 1, 2007

First QC Date

April 4, 2007

Last Update Submit

August 14, 2007

Conditions

Keywords

Coronary artery diseaseHDL-CholesterolEndothelial FunctionEndothelial Progenitor Cellsnormal blood HDL-Cholesterol level

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Type 1 or 2 diabetes mellitus
  • Acute coronary syndrome
  • Unstable angina pectoris
  • Myocardial infarction during the last 8 weeks
  • Therapy with niacin
  • Active infections
  • Ventricular arrhythmias
  • Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg
  • Cancer
  • Pregnant or lactating
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Helmut Drexler, MD

    Hannover Medical School

    STUDY DIRECTOR
  • Ulf Landmesser, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR
  • Kristina Sonnenschein, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

April 1, 2007

Study Completion

April 1, 2008

Last Updated

August 15, 2007

Record last verified: 2007-04

Locations