Suggestive Effects on the Diameter of Coronary Arteries (SUGO-KO)
Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
The aim of this randomized controlled pilot study was to answer the following questions:
- Is it possible to affect the diameter of coronary arteries through a placebo injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
- Is it possible to affect the diameter of coronary arteries through a pharmacologically underdosed nitroglycerine injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
調査の概要
詳細な説明
The present study is a randomized controlled double-blind single center study in order to investigate the effects of verbal suggestions ('vasodilatation') in combination with either a placebo-intervention (sodium chloride 0.9%) or an underdosed vasodilating medication (nitroglycerine) on the diameter of coronary arteries. 60 patients with a clinical indication to undergo a coronary angiogram were recruited in the German Heart Centre Munich. Patients with acute myocardial events and the necessity for coronary intervention were excluded from the study. Patients were randomized into one of four arms of the two experiments:
Experiment A: Intracoronary (i.c.) placebo-infusion together with a standardized verbal suggestion of coronary vasodilation vs. i.c. placebo-infusion without verbal suggestion.
Experiment B: i.c. infusion of a very low dosed nitroglycerin together with a standardized verbal suggestion of coronary vasodilation vs. i.c. nitroglycerine infusion without verbal suggestion.
To our best knowledge this study is the first to investigate the modulating effects of verbal suggestions going along with medical interventions on the diameter of coronary arteries during heart catheterization.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Munich、ドイツ、81675
- Department of Psychosomatic Medicine, Technische Universität München
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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
説明
Inclusion Criteria:
- medical indication for heart catheterization
- written informed consent
Exclusion Criteria:
- acute myocardial infarction
- acute elevation of cardiac enzymes
- regular intake of drugs containing nitroglycerin
- intolerance of nitroglycerin
- hypotension
- renal insufficiency
- diabetes mellitus
- hyperthyroidism
- pregnancy
- acute psychiatric disease
- cognitive impairment
- prinzmetal's angina
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
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Sodium chloride
Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride
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Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
実験的：Sodium chloride and verbal suggestions
Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels
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Verbal suggestions of a vasodilatory effect on cardiac vessels
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|
アクティブコンパレータ：Nitroglycerin
Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
実験的：Nitroglycerin and verbal suggestions
Control arm "B": Open intracoronary infusion of 0.01 mg nitroglycerin in 5 ml sodium chloride plus the suggestion of a vasodilatory effect on cardiac vessels
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
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 |
時間枠 |
|---|---|
|
Stenosis Diameter (Quantitative Coronary Analysis)
時間枠：60 sec after intervention
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60 sec after intervention
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Heart rate
時間枠：immediately before and after intervention
|
immediately before and after intervention
|
|
Systolic blood pressure
時間枠：immediately before and after intervention
|
immediately before and after intervention
|
|
Diastolic blood pressure
時間枠：immediately before and after intervention
|
immediately before and after intervention
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Chest Pain
時間枠：immediately before and after intervention
|
immediately before and after intervention
|
|
Subjective distress
時間枠：immediately before and after intervention
|
immediately before and after intervention
|
協力者と研究者
捜査官
- 主任研究者：Joram Ronel, M.D.、Technical University of Munich
- 主任研究者：Karin Meißner, M.D.、Ludwig-Maximilians-Universität München
- 主任研究者：Julinda Mehilli, M.D.、Deutsches Herzzentrum München
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。