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Acute Hemodynamic and Biological Effects of ECP and Exercise

Primary Purpose

Patients With Stable Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hemodynamic and biological measurements
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Stable Coronary Artery Disease focused on measuring ECP, Endurance exercise, myocardial perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years, written informed consent to participate in the study

Exclusion Criteria:

  • 1. Pregnancy (serum β-HCG<2 IU/l for all female volunteers)

Baseline History:

  1. Endurance exercise 5 days before and the days between the exams
  2. History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder
  3. History of metabolic disorder, particularly diabetes mellitus
  4. History of respiratory, renal, hepatic or cerebral disease
  5. Allergic reactions to Luminity or its components
  6. Cardiovascular medication
  7. Illness characterized by acute phase response
  8. Anaemia with haemoglobin levels < 110 g/L

Baseline Physical Examination:

1. Peripheral artery disease

Baseline Echocardiogram:

  1. Valvular heart disease
  2. Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta)
  3. Intra- or extracardiac shunt
  4. Systolic or diastolic left ventricular (LV) dysfunction
  5. LV-hypertrophy
  6. Pulmonary arterial hypertension

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

half supine bicycle Exercise

ECP

Arm Description

60 minutes of half supine bicycle exercise with submaximal workload

90 minutes of ECP

Outcomes

Primary Outcome Measures

Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)

Secondary Outcome Measures

Puls Wave Velocity Analysis

Full Information

First Posted
April 5, 2011
Last Updated
December 11, 2013
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02014090
Brief Title
Acute Hemodynamic and Biological Effects of ECP and Exercise
Official Title
Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Stable Coronary Artery Disease
Keywords
ECP, Endurance exercise, myocardial perfusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
half supine bicycle Exercise
Arm Type
Active Comparator
Arm Description
60 minutes of half supine bicycle exercise with submaximal workload
Arm Title
ECP
Arm Type
Active Comparator
Arm Description
90 minutes of ECP
Intervention Type
Other
Intervention Name(s)
Hemodynamic and biological measurements
Intervention Description
by MCE, PWA, Doppler, Multiplex, FACS
Primary Outcome Measure Information:
Title
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
Time Frame
During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
Secondary Outcome Measure Information:
Title
Puls Wave Velocity Analysis
Time Frame
At baseline & post intervention, expected to be on average 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years, written informed consent to participate in the study Exclusion Criteria: 1. Pregnancy (serum β-HCG<2 IU/l for all female volunteers) Baseline History: Endurance exercise 5 days before and the days between the exams History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder History of metabolic disorder, particularly diabetes mellitus History of respiratory, renal, hepatic or cerebral disease Allergic reactions to Luminity or its components Cardiovascular medication Illness characterized by acute phase response Anaemia with haemoglobin levels < 110 g/L Baseline Physical Examination: 1. Peripheral artery disease Baseline Echocardiogram: Valvular heart disease Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta) Intra- or extracardiac shunt Systolic or diastolic left ventricular (LV) dysfunction LV-hypertrophy Pulmonary arterial hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Gloekler, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano de Marchi, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Rimoldi, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Seiler, MD
Organizational Affiliation
University of Bern
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Acute Hemodynamic and Biological Effects of ECP and Exercise

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