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OpenTrials
Completed

NCT Number: NCT02014090

Acute Hemodynamic and Biological Effects of ECP and Exercise

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.

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Key information

Conditions

Patients With Stable Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

Hemodynamic and biological measurements

Other

by MCE, PWA, Doppler, Multiplex, FACS

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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.