Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon (TAHITI)
Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon (STEMI) Patients: 1-year Follow-up of the Prospective Randomised TAHITI Study
Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on admission have high rates of mortality (1). The management of hyperglycemic patients during STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients (2).
Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI undergoing quantitative coronary angiography were studied. Patients were categorized in two groups, either treated by thrombus aspiration v/s patients treated without thrombus aspiration. After discharge from the hospital, all patients will be managed and followed quarterly for 12 months month after event, as outpatients, to perform clinical evaluation, routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary disease and heart failure.
Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA before PCI, as compared to hyperglycemic patients treated only by PCI.
調査の概要
詳細な説明
The data analyzed in this study will be obtained from hyperglycemic STEMI patients who underwent primary PCI at the Department of Cardiology of the Cardarelli Hospital in Naples Italy between June 1, 2016, and December 1, 2017. This will be a prospective study to compare two therapeutic strategies: PCI plus thrombus aspiration (TA) versus PCI alone in patients with STEMI and hyperglycemia. According to the recent statement by the American Heart Association, hyperglycemia will be defined as an admission plasma glucose level of >140 mg/dl. Inclusion criteria will include: age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level of >140 mg/dl. All STEMI patients will be referred to the cardiac catheterization laboratory within 12 h of presentation. Patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting, or had received fibrinolytic therapy will be excluded from the study. The following patients will be referred for urgent invasive diagnostics with the intention of performing PCI: symptom duration of 12 hours or less and ST-segment elevation of 0.1 mV or greater in at least 2 contiguous leads (≥0.2 mV in V1-V3) or presumed new-onset left bundle-branch block. The investigation will be conformed with the principles outlined in the Declaration of Helsinki for use of human tissue or subjects. The Institutional Review Board will approve the protocol.
Outcomes The primary outcome of the THAITI study will be all-cause mortality, cardiovascular deaths, recurrent myocardial infarction, cardiogenic shock, and class IV heart failure within 360 days. Other outcomes will include target vessel revascularisation, stent thrombosis, stroke, and transient ischaemic attack within 360 days.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Naples、イタリア、80100
- Cardarelli Hospital
-
-
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:
- age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level ( >140 mg/dl in hyperglycemic Group).
Exclusion Criteria:
- patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting.
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 |
|---|---|
|
STEMI TA hyperglycemic subjects
STEMI hyperglycemic patients, percutaneous coronary intervention with TA
|
Percutaneous coronary intervention.
Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion.
A minimum of two syringes (40 mL) of aspirate will be recommended.
The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter.
The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus.
PCI procedure will be done without thrombectomy as per the investigator.
Direct stenting will not be mandated in either treatment group.
Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy.
The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.
|
|
STEMI without TA hyperglycemic subjects
STEMI hyperglycemic patients, percutaneous coronary intervention without TA
|
Percutaneous coronary intervention.
Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion.
A minimum of two syringes (40 mL) of aspirate will be recommended.
The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter.
The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus.
PCI procedure will be done without thrombectomy as per the investigator.
Direct stenting will not be mandated in either treatment group.
Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy.
The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.
|
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 |
|---|---|---|
|
cardiovascular death
時間枠：12 months
|
death caused by loss of heart function such as sudden cardiac arrest or heart attack (myocardial infarction).
ECG and cardiac damage markers
|
12 months
|
|
recurrent myocardial infarction
時間枠：12 months
|
Myocardial infarction when there is a blockage in one or more of the arteries to the heart, preventing the heart from receiving enough oxygen-rich blood.
If the oxygen in the blood cannot reach the heart muscle, the heart becomes damaged.
ECG and cardiac damage markers
|
12 months
|
|
heart failure.
時間枠：12 months
|
Heart failure develops when the heart, via an abnormality of cardiac function (detectable or not), fails to pump blood at a rate commensurate with the requirements of the metabolizing tissues or is able to do so only with an elevated diastolic filling pressure.
ECG and echocardiography
|
12 months
|
|
acute coronary syndrome
時間枠：12 months
|
non-ST-elevation acute coronary syndromes (ACSs) and unstable angina.
ECG and cardiac damage markers
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Target vessel revascularisation
時間枠：12 months
|
Target lesion revascularization was defined as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent.
Target lesion revascularization was considered to be ischemia-driven if the target lesion diameter stenosis was ≥50% by quantitative analysis with either electrocardiographic changes at rest or a positive functional study in the distribution of the target lesion, or ≥70% with recurrent symptoms only.
Angiography study
|
12 months
|
|
stent thrombosis,
時間枠：12 months
|
Definite or confirmed event with symptoms suggestive of an acute coronary syndrome and angiographic or pathologic confirmation of stent thrombosis.Angiography study
|
12 months
|
|
stroke
時間枠：12 months
|
The sudden death of brain cells due to lack of oxygen, caused by blockage of blood flow or rupture of an artery to the brain.
Symptoms: Sudden loss of speech, weakness, or paralysis of one side of the body.
CAT scans
|
12 months
|
|
transient ischaemic attack
時間枠：12 months
|
.A transient ischemic attack (TIA) is like a stroke, producing similar symptoms, but usually lasting only a few minutes and causing no permanent damage.CAT scans
|
12 months
|
協力者と研究者
捜査官
- スタディディレクター：Celestino Sardu, MD, PHD、University of Campania "Luigi Vanvitelli"
出版物と役立つリンク
一般刊行物
- Jones DA, Rathod KS, Gallagher S, Jain AK, Kalra SS, Lim P, Crake T, Ozkor M, Rakhit R, Knight CJ, Iqbal MB, Dalby MC, Malik IS, Whitbread M, Mathur A, Redwood S, MacCarthy PA, Weerackody R, Wragg A. Manual Thrombus Aspiration Is Not Associated With Reduced Mortality in Patients Treated With Primary Percutaneous Coronary Intervention: An Observational Study of 10,929 Patients With ST-Segment Elevation Myocardial Infarction From the London Heart Attack Group. JACC Cardiovasc Interv. 2015 Apr 20;8(4):575-84. doi: 10.1016/j.jcin.2014.11.021.
- Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P; American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2008 Mar 25;117(12):1610-9. doi: 10.1161/CIRCULATIONAHA.107.188629. Epub 2008 Feb 25. Erratum In: Circulation. 2010 Jun 15;121(23):e444.
- Tilsted HH, Olivecrona GK. To Aspirate or Not to Aspirate: That Is the Question. JACC Cardiovasc Interv. 2015 Apr 20;8(4):585-7. doi: 10.1016/j.jcin.2015.01.014. No abstract available.
- Sardu C, Barbieri M, Balestrieri ML, Siniscalchi M, Paolisso P, Calabro P, Minicucci F, Signoriello G, Portoghese M, Mone P, D'Andrea D, Gragnano F, Bellis A, Mauro C, Paolisso G, Rizzo MR, Marfella R. Thrombus aspiration in hyperglycemic ST-elevation myocardial infarction (STEMI) patients: clinical outcomes at 1-year follow-up. Cardiovasc Diabetol. 2018 Nov 29;17(1):152. doi: 10.1186/s12933-018-0795-8. Erratum In: Cardiovasc Diabetol. 2018 Dec 27;17(1):159.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。
percutaneous coronary interventionの臨床試験
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
-
University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
-
Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない