NON-Invasive Examinations of Coronary Artery Disease (NONCAD)
調査の概要
状態
条件
詳細な説明
The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:
Substudy NITRO
Purpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.
The participants are instructed to alternate between rest and Nitroglycerine as treatment for chest pain attacks during a 2 week period. Chest pain score is recorded in a diary handed out at day 1 together with 30 tablets Nitroglycerine in the maximal tolerated dose.
Substudy SCORE
Aim: To test and compare the ability of different statistical methods using clinical data to predict the presence of narrowed coronary arteries in a contemporary Danish population.
Substudy CONTRAST
Aim: To evaluate if the blood flow in an area in the heart muscle measured by contrast adenosine stress echocardiography can predict the presence of significant stenosis in the coronary artery supplying the area.
Substudy 2D strain
Aim: To Evaluate if lack of increase in 2D strain during adenosine stress echocardiography can predict the presence of narrowed coronary arteries.
Substudy SPECT
Aim: To evaluate whether the result of a myocardial scintigraphy can predict symptomatic chest pain relief 6 months after a coronary angiography and possible treatment with balloon or bypass surgery.
Participants: Annually around 1,500 coronary angiographies are performed at Region Hospital Herning. We intend to include 200 patients referred by their physicians to coronary angiography in the study and expect the data collection phase to last 3 years.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Herning、デンマーク、7400
- 募集
- Cardiovascular Research Unit, Regionhospital Herning
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コンタクト：
- Ole May, MD, Ph.D.
- 電話番号：+4599272088
- メール：hecom@ringamt.dk
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コンタクト：
- Ole May, MD, Ph.D.
- 電話番号：+4526175575
- メール：hecom@ringamt.dk
-
主任研究者：
- Ole May, MD, Ph.D.
-
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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:
- Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
- Signed written informed consent
- Sinus rhythm (ECG)
- Age above 18 years
Exclusion Criteria:
- Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
- CA performed earlier in life
- Known significant cardiac valve disease
- Asthma (not COPD)
- Incapable of performing an exercise test
- Malignant Disease
- Senile dementia or other conditions causing impaired cooperation
- Previous participation in the project
- NTG intolerance
- Pregnancy
- Bundle branch block (QRS > 120 ms)
ECG changes:
- Pathologic Q-wave in at least two leads:
- QS-complex or Q-wave > 0.02 sec. in V2-V3
- QS-complex or Q-wave > 0.03 sec. and > 0.1 mV in I, II, aVL, aVF or V4-V6
- Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern
- Brady pacemaker
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
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ole May, MD, Ph.D.、Cardiovascular Research Unit
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
冠動脈疾患の臨床試験
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