Ischemic Heart DiseaseNCT01112163
The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
A study testing Enhanced external counter pulsation in people with Ischemic Heart Disease, run by Herning Hospital at 1 site in Denmark.
Trial summary
Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic heart disease. The treatment improves physical capacity and relieves angina pectoris. It is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Enhanced external counter pulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Nov 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angina pectoris, CCS-class 2-4
- Reversal ischemia
- Pathological coronary angiogram without the possibility of revascularization
- Sinus rhythm
Who cannot join
- Cancer
- Dementia
- Pregnancy
- Blood pressure > 180/110
- Severe valvular disease
- Ejection fraction < 25%
Show all 13Show fewer
- Acute coronary syndrome the last 3 months
- History of aortic aneurism
- Pacemaker
- Diabetes mellitus
- Cardiac arrythmia that prevents the EECP procedure
- Bleeding
- Active venous thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic heart disease. The treatment improves physical capacity and relieves angina pectoris. It is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. Some studies demonstrate a relationship between diastolic and systolic blood pressure ratio (d/s ratio) and the effect of EECP.
The aim of the investigators study is to understand the effect of EECP on left ventricular systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).
Read more
Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60 min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave velocity, a measure of aortic arterial stiffness, in order to investigate the relationship between the d/s ratio and arterial stiffness.
The patients would be recruited among former study patients who have undergone EECP before. 20 patients with the best acoustic conditions would be selected and invited to enroll into the study.
- Conditions
- Ischemic Heart Disease
- Being tested
- Enhanced external counter pulsation
- Keywords
- ischemic heart disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced external counter pulsationDevice
While an individual is undergoing ECP, they have pneumatic stockings (also known as cuffs) on their legs and are connected to telemetry monitors that monitor their heart rate and rhythm.The cuffs should ideally inflate at the beginning of diastole and deflate at the beginning of systole. During the inflation portion of the cycle, the calf cuffs inflate first, then the lower thigh cuffs and finally the upper thigh cuffs. Inflation is controlled by a pressure monitor, and the cuffs are inflated to about 300 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced external counter pulsation | Experimental | One session of enhanced external counter pulsation (60 minutes) Receives: Device: Enhanced external counter pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular longitudinal strain
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
Measured: 60 minutes
Secondary outcomes (2)
Pulse wave velocity
Pulse wave velocity is a measure of aortic arterial stiffness. The outcome is the relationhip between pulse wave velocity and d/s ratio
Measured: 60 minutes
left ventricular diastolic function
EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ashkan Eftekhari, MD PhD, Principal investigator, Regionshospitalet Herning / Dept. Pharmacology Aarhus UniversityOle May, MD PhD, Study chair, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112163
- Sponsor's protocol ID
- EECP-VV
- Status last verified
- Mar 2010
- First submitted
- 26 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
May O, Sogaard HJ. Enhanced External Counterpulsation Is an Effective Treatment for Depression in Patients With Refractory Angina Pectoris. Prim Care Companion CNS Disord. 2015 Aug 20;17(4):10.4088/PCC.14m01748. doi: 10.4088/PCC.14m01748. eCollection 2015.
PubMed 26693035
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
- ClinicalTrials.gov ID
- NCT01112163
- Acronym / sponsor ID
- EECP-VV
- Conditions
- Ischemic Heart Disease
- Keywords
- ischemic heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 28 Apr 2010 (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.
Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic heart disease. The treatment improves physical capacity and relieves angina pectoris. It is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. Some studies demonstrate a relationship between diastolic and systolic blood pressure ratio (d/s ratio) and the effect of EECP.
The aim of the investigators study is to understand the effect of EECP on left ventricular systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).
Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60 min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave velocity, a measure of aortic arterial stiffness, in order to investigate the relationship between the d/s ratio and arterial stiffness.
The patients would be recruited among former study patients who have undergone EECP before. 20 patients with the best acoustic conditions would be selected and invited to enroll into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced external counter pulsation | Experimental | Device: Enhanced external counter pulsationOne session of enhanced external counter pulsation (60 minutes) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Angina pectoris, CCS-class 2-4
- Reversal ischemia
- Pathological coronary angiogram without the possibility of revascularization
- Sinus rhythm
Key exclusion criteria (13 listed)
- Cancer
- Dementia
- Pregnancy
- Blood pressure > 180/110
- Severe valvular 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 |
|---|---|---|
| Enhanced external counter pulsationWhile an individual is undergoing ECP, they have pneumatic stockings (also known as cuffs) on their legs and are connected to telemetry monitors that monitor their heart rate and rhythm.The cuffs should ideally inflate at the beginning of diastole and deflate at the beginning of systole. During the inflation portion of the cycle, the calf cuffs inflate first, then the lower thigh cuffs and finally the upper thigh cuffs. Inflation is controlled by a pressure monitor, and the cuffs are inflated to about 300 mmHg. | Device | Enhanced external counter pulsation |
Primary outcome
Left ventricular longitudinal strain
Time frame: 60 minutes
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
2 secondary outcomes
Pulse wave velocity
Time frame: 60 minutes
left ventricular diastolic function
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Derived from this study: PubMed 26693035May O, Sogaard HJ. Enhanced External Counterpulsation Is an Effective Treatment for Depression in Patients With Refractory Angina Pectoris. Prim Care Companion CNS Disord. 2015 Aug 20;17(4):10.4088/PCC.14m01748. doi: 10.4088/PCC.14m01748. eCollection 2015.
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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.
Ashkan Eftekhari, MD PhD principal investigator
Regionshospitalet Herning / Dept. Pharmacology Aarhus University
Ole May, MD PhD study chair
Herning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced external counter pulsation in people with Ischemic Heart Disease, run by Herning Hospital at 1 site in Denmark.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Apr 2010. 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 Denmark. 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?
Results are not available in the source record.
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?
Left ventricular longitudinal strain (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112163, which also lists 1 linked publication.
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 28 Apr 2010.