- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014090
Acute Hemodynamic and Biological Effects of ECP and Exercise
December 11, 2013 updated by: Christian Seiler, University Hospital Inselspital, Berne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bern, Switzerland, 3010
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: half supine bicycle Exercise
60 minutes of half supine bicycle exercise with submaximal workload
|
by MCE, PWA, Doppler, Multiplex, FACS
|
Active Comparator: ECP
90 minutes of ECP
|
by MCE, PWA, Doppler, Multiplex, FACS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
Time Frame: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
|
During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Puls Wave Velocity Analysis
Time Frame: At baseline & post intervention, expected to be on average 90 minutes
|
At baseline & post intervention, expected to be on average 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefano de Marchi, MD, University of Bern
- Principal Investigator: Stefano Rimoldi, MD, University of Bern
- Study Director: Christian Seiler, MD, University of Bern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
April 5, 2011
First Submitted That Met QC Criteria
December 11, 2013
First Posted (Estimate)
December 17, 2013
Study Record Updates
Last Update Posted (Estimate)
December 17, 2013
Last Update Submitted That Met QC Criteria
December 11, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 177/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Stable Coronary Artery Disease
-
Centre Hospitalier Universitaire DijonCompletedPatients Undergoing Cardiac Surgery | Patients With Coronary Artery Bypass Surgery With CECFrance
-
Sohag UniversityRecruitingAngiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery DiseasesEgypt
-
University of ÉvoraCompletedPatients With Coronary Artery DiseasePortugal
-
Hospices Civils de LyonCompletedStable Angina | Multivessel Coronary Artery Disease | Vessel Disease | Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction | Patients With ST-elevated Myocardial Infarction | Revascularization of Culprit Coronary ArteryFrance
-
Sohag UniversityCompletedPatients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same PatientsEgypt
-
Qilu Hospital of Shandong UniversityCompletedMajor Adverse Cardiovascular Events in Patients With Coronary Artery DiseaseChina
-
University Health Network, TorontoStony Brook University; York UniversityCompletedCoronary Artery Disease | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Chronic Stable Heart Failure | Coronary Artery Bypass Graft Surgery, With or Without Valve SurgeryCanada
-
Ajou University School of MedicineB. Braun Korea Co., Ltd.UnknownStable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery DiseaseKorea, Republic of
-
Wanbangde Pharmaceutical Group Co., LTDThe First Affiliated Hospital, Guangzhou University of Traditional Chinese...UnknownStable Angina Pectoris Associated With DepressionChina
-
Shanghai 10th People's HospitalUnknownPatients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
Clinical Trials on Hemodynamic and biological measurements
-
Fondazione IRCCS San Gerardo dei TintoriRecruitingVery Low Birth Weight Infant | Very Preterm Maturity of InfantItaly
-
CareTaker Medical LLCUniversity of Virginia; Yale School of Medicine; Orange County Research CenterCompletedBlood Pressure | Heart Rate Variability | Cardiac Output | Left Ventricular Ejection TimeUnited States
-
Institut universitaire de cardiologie et de pneumologie...RecruitingAortic Valve Stenosis | Prosthesis Failure | Aortic Valve RegurgitationCanada
-
University Health Network, TorontoRecruitingRespiratory Insufficiency | Lung Injury | Mechanical Ventilation Complication | Diaphragm Injury | Abdominal Muscle StrainedCanada
-
University of California, Los AngelesEnrolling by invitationPulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited States
-
University of California, Los AngelesEnrolling by invitationPulmonary Disease | Pulmonary Embolism | Pulmonary Embolus/Emboli | Pulmonary Embolism and Thrombosis | Pulmonary Embolism Subacute Massive | Pulmonary Embolism Acute MassiveUnited States
-
Abbott Medical DevicesCompletedHeart FailureAustria, France, Italy
-
Institut Louis MalardéInstitut Pasteur; Institut National en Santé Publique du Québec; Institut de... and other collaboratorsCompletedCommunicable Diseases | Microbiome | Non Communicable Diseases | Metal Poison | Pesticide Exposure | Genetics Population | CiguateraFrench Polynesia
-
Universidad Miguel Hernandez de ElcheEuropean Research CouncilRecruitingDiabetes Mellitus, Type 2Ecuador