Ischemic Heart Disease Clinical Trial
— REMOTEOfficial title:
Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
Verified date | November 2016 |
Source | University Medicine Greifswald |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
The purpose of this study is to investigate if remote ischemic preconditioning by combining limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better results in preconditioning the human heart than limb ischaemia alone does.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - planned PCI of one of the main coronary artery (artery diameter distal of the stenotic area at least 2,5 mm) - patient age 18 years or older - stable angina pectoris symptoms Exclusion Criteria: - presence of collateral vessels - electrocardiographic bundle branch blocks - multiple coronary stenosis - occlusion of a coronary artery - renal insufficiency (GFR (MDRD) < 50 ml/min/1,73 m2) - presence of coronary bypass grafts - history or presence of myocardial infarction. - echocardiographic signs of left ventricular hypertrophy (septal and/or posterior wall diameter greater than 14 mm) - some sort of medications (adenosine, morphine and derivates, immunosuppressive agents, oral antibiotics, theophyllin, alpha receptor blockers) - peripheral arterial disease - exercise tests performed within 24 h before study start. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Ernst Moritz Arndt Universität Greifswald | Greifswald | MVP |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ST deviation | Immediately after the preconditioning cycle the PCI ballon will be positioned in the coronary artery lesion and inflated for 2 minutes followed by 5 minutes of reperfusion. This cycle will be repeated for 3 times without any interruption. Intracoronary ECGs and 12 lead surface ecgs will be taken immediately before and at the end of each ballon inflation (two minutes after beginning the intracoronary ballon inflation). after taking the ecgs the ballon will be deflated. The st-deviations will be analysed. |
120 seconds after angioplasty | No |
Secondary | troponin I | Troponin levels will be evaluated 24 h after PCI | 24 hours after PCI | No |
Secondary | chest pain (Maximum) | the maximal chest pain occuring during each of the Pci balloon inflations will be documented as a number out of 10. 0 is determined as no pain and 10 is determined as the heaviest pain which the patient ever experienced. A specific timepoint has not been defined. | time period 2 minutes | No |
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