## Protocol Section
### Identification Module
**NCT ID:** NCT00457379

**Acronym:** HERCET

**Brief Title:** Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-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

#### Organization Study ID Info
**ID:** 4031214
#### Organization
**Class:** OTHER
**Full Name:** Hannover Medical School
### Status Module
#### Completion Date
**Date:** 2008-04

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2007-08-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-08-14

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2007-04

**Status Verified Date:** 2007-04

#### Study First Post Date
**Date:** 2007-04-06
**Type:** ESTIMATED
**Study First Submit Date:** 2007-04-04
**Study First Submit QC Date:** 2007-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hannover Medical School

### Description Module

**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.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- Coronary artery disease

- HDL-Cholesterol

- Endothelial Function

- Endothelial Progenitor Cells

- normal blood HDL-Cholesterol level

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** physical exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training

#### Secondary Outcomes

**Measure:** flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Landmesser.Ulf@MH-Hannover.de

**Name:** Ulf Landmesser, MD

**Phone:** +49511532

**Phone Ext:** 2229

**Role:** CONTACT

**Contact 2:**

**Email:** Sonnenschein.Kristina@MH-Hannover.de

**Name:** Kristina Sonnenschein

**Phone:** +49511532

**Phone Ext:** 5402

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hannover

**Contacts:**

***Contact 1:***

- **Email:** Ulf.Landmesser@MH-Hannover.de

- **Name:** Ulf Landmesser, MD

- **Phone:** +49511532

- **Phone Ext:** 2229

- **Role:** CONTACT

***Contact 2:***

- **Email:** Sonnenschein.Kristina@MH-Hannover.de

- **Name:** Kristina Sonnenschein

- **Phone:** +49511532

- **Phone Ext:** 5402

- **Role:** CONTACT

***Contact 3:***

- **Name:** Ulf Landmesser, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** Hannover Medical School

**Status:** RECRUITING

**Zip:** 30625

#### Overall Officials

**Official 1:**

**Affiliation:** Hannover Medical School

**Name:** Helmut Drexler, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Hannover Medical School

**Name:** Ulf Landmesser, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Hannover Medical School

**Name:** Kristina Sonnenschein, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Misc Info Module

- Version Holder: 2024-05-24
