Patients With Stable Coronary Artery DiseaseNCT02014090
Acute Hemodynamic and Biological Effects of ECP and Exercise
A study testing Hemodynamic and biological measurements in people with Patients With Stable Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Stable Coronary Artery Disease
- What is being tested?
- Hemodynamic and biological measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years, written informed consent to participate in the study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
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.
- Being tested
- Hemodynamic and biological measurements
- Keywords
- ECP, Endurance exercise, myocardial perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic and biological measurementsOther
by MCE, PWA, Doppler, Multiplex, FACS
| Study group | Role | What they receive |
|---|---|---|
| half supine bicycle Exercise | Active comparator | 60 minutes of half supine bicycle exercise with submaximal workload Receives: Other: Hemodynamic and biological measurements |
| ECP | Active comparator | 90 minutes of ECP Receives: Other: Hemodynamic and biological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
Measured: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
Secondary outcomes (1)
Puls Wave Velocity Analysis
Measured: At baseline & post intervention, expected to be on average 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMar 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Seiler, Insel Gruppe AG, University Hospital Bern
- Investigators
- Steffen Gloekler, MD, Principal investigator, University of BernStefano de Marchi, MD, Principal investigator, University of BernStefano Rimoldi, MD, Principal investigator, University of BernChristian Seiler, MD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014090
- Sponsor's protocol ID
- 177/07
- Status last verified
- Dec 2013
- First submitted
- 5 Apr 2011
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02014090
- Acronym / sponsor ID
- 177/07
- Keywords
- ECP, Endurance exercise, myocardial perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| half supine bicycle Exercise | Active comparator | Other: Hemodynamic and biological measurements60 minutes of half supine bicycle exercise with submaximal workload |
| ECP | Active comparator | Other: Hemodynamic and biological measurements90 minutes of ECP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 18 years, written informed consent to participate in the study
Key exclusion criteria (19 listed)
- 1. Pregnancy (serum β-HCG<2 IU/l for all female volunteers)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic and biological measurementsby MCE, PWA, Doppler, Multiplex, FACS | Other | ECP, half supine bicycle Exercise |
Primary outcome
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
Time frame: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
1 secondary outcome
Puls Wave Velocity Analysis
Time frame: At baseline & post intervention, expected to be on average 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic and biological measurements in people with Patients With Stable Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE) (time frame: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.