Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI) (REMOTE)
Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
調査の概要
状態
条件
詳細な説明
It has been demonstrated that protection from ischemia reperfusion can be achieved by brief periods of ischemia applied at a remote site during an injurious ischemic event (remote postconditioning). The purpose of this study is to investigate if the combination of brief periods of limb ischemia in combination with electric muscle stimulation at the same site could exceed the preconditioning effect of limb ischemia alone.
Therefore the investigators thought to perform 2 different forms of remote ischaemic preconditioning in patients undergoing elective coronary angioplasty.
In the first patient group a blood pressure cuff will be applied at the lower leg. Ischemia will be induced by inflating the cuff to a pressure of 200 mmHg for 5 minutes. Afterwards reperfusion will be allowed for further 5 minutes. This cycle will be repeated 3 times.
In a second patient group electric muscle stimulation at the same site (HiToP 191) will be performed additionally throughout the whole preconditioning cycle.
After preconditioning, the percutaneous coronary intervention (PCI) will be performed by 3 PCI-ballon inflations, each lasting for 2 minutes. Between the inflations coronary reperfusion will be allowed for 5 minutes.
The Effects of preconditioning will be evaluated by analysing the ST-deviation, caused by angioplasty in an intracoronary (derived by PCI wire) and surface ecg.
Also the maximum of chest pain during the 3 inflation cycles and troponin levels 24 h after PCI will be evaluated.
研究の種類
連絡先と場所
研究場所
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MVP
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Greifswald、MVP、ドイツ、17489
- Ernst Moritz Arndt Universität Greifswald
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
control group
A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg but without inflating the cuff and without stimulating the muscle.
Now 25 minutes will have to pass by before beginning the coronary angioplasty.
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|
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intervention group 1
A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg.
The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes.
Next reperfusion will be allowed for 5 minutes.
This cycle will be repeated for 3 times.
There will be no electrical muscle stimulation in this group.
|
A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg.
The blood pressure cuff will be inflated with 200 mmHg for 5 minutes.
Next reperfusion will be allowed for 5 minutes.
This cycle will be repeated for 3 times.
|
|
intervention group 2
A Blood pressure cuff and the muscle stimulator pads will be applied to one lower leg.
The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes.
Next reperfusion will be allowed for 5 minutes.
This cycle will be repeated for 3 times.
In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle
|
A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg.
The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes.
Next reperfusion will be allowed for 5 minutes.
This cycle will be repeated for 3 times.
In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ST deviation
時間枠：120 seconds after angioplasty
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
troponin I
時間枠：24 hours after PCI
|
Troponin levels will be evaluated 24 h after PCI
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24 hours after PCI
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chest pain (Maximum)
時間枠：time period 2 minutes
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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.
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time period 2 minutes
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協力者と研究者
捜査官
- 主任研究者：Markus Reinthaler, MD、Ernst Moritz Arndt University Greifswald
- 主任研究者：Thorsten Reffelmann, MD、Ernst Moritz Arndt University Greifswald
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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