The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
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| First Received Date ICMJE | April 26, 2010 | ||||||
| Last Updated Date | April 27, 2010 | ||||||
| Start Date ICMJE | March 2010 | ||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Left ventricular longitudinal strain [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function | ||||||
| Official Title ICMJE | The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function | ||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase | Not Provided | ||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ischemic Heart Disease | ||||||
| Intervention ICMJE | Device: Enhanced external counter pulsation
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. |
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| Study Arm (s) | Experimental: Enhanced external counter pulsation
One session of enhanced external counter pulsation (60 minutes)
Intervention: Device: Enhanced external counter pulsation |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||
| Estimated Enrollment ICMJE | 20 | ||||||
| Estimated Completion Date | November 2010 | ||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||
| Ages | 18 Years to 80 Years (Adult, Senior) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Denmark | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01112163 | ||||||
| Other Study ID Numbers ICMJE | EECP-VV | ||||||
| Has Data Monitoring Committee | No | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | Medicinsk Afdeling Regionshospitalet Herning, Hospitalenheden Vest | ||||||
| Study Sponsor ICMJE | Herning Hospital | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| Information Provided By | Herning Hospital | ||||||
| Verification Date | March 2010 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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