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CompletedNCT02014090Updated Dec 17, 2013

Acute Hemodynamic and Biological Effects of ECP and Exercise

An interventional study of Hemodynamic and biological measurements in Patients With Stable Coronary Artery Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-17.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With Stable Coronary Artery Disease

Keywords

  • ECP
  • Endurance exercise
  • myocardial perfusion
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 20 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    half supine bicycle Exercise

    60 minutes of half supine bicycle exercise with submaximal workload

    Other: Hemodynamic and biological measurements

  • Active comparator
    ECP

    90 minutes of ECP

    Other: Hemodynamic and biological measurements

Interventions

  • OtherHemodynamic and biological measurements

    by MCE, PWA, Doppler, Multiplex, FACS

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Puls Wave Velocity Analysis

    Time frame: At baseline & post intervention, expected to be on average 90 minutes

07

Study locations

1 site
  • University Hospital
    Bern, 3010, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02014090
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Christian Seiler (Prof Dr med, Insel Gruppe AG, University Hospital Bern) — Principal investigator
First posted
Dec 17, 2013
Start date
Mar 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Dec 17, 2013

Study contacts

Steffen Gloekler, MD
principal investigator · University of Bern
Stefano de Marchi, MD
principal investigator · University of Bern
Stefano Rimoldi, MD
principal investigator · University of Bern
Christian Seiler, MD
study director · University of Bern

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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