Clinical Registry on Sudden Death Primary Prevention at Latin America (ESCAPE-ICD)
Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)
INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.
OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading primary prevention by the means of clinical evidence on real risk of death in this group of patients.
REGISTRY DESIGN:
- retrospective (at stage 1); prospective (at stage 2)
- multi-center (minimum 25-30 centres)
- international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)
- non randomized.
- Sample size: at screening about 12.500 patients and 962 patients at treatment stage
REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).
調査の概要
詳細な説明
REGISTRY STAGES 2 stages will be performed:
- Stage 1 (Screening): 12500 patients with MI and LVEF<40% will be evaluated, to know ICD implantation prevalence in such patients at Latin American countries
- Stage 2 (Treatment): after patient screening and as per clinical decision, 962 patients will be entered in group 1 and 2 (481 each, 1:1)
STEERING COMMITTEE
- Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina
- Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia
CLINICAL ASSESSMENT
• Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain
REGISTRY DURATION
- Patient enrollment period initiation: September 2011
- End of patient enrollment: September 2013
- End of FUs: September 2018
- Registry closure and data analyses: 4Q 2018.
REGULATORY CONSIDERATIONS As this is an observational registry, no submission to National Authorities is required.
研究の種類
連絡先と場所
研究場所
-
-
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Tucuman、アルゼンチン
- Centro Privado de Cardiología
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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:
- Patients that had Acute Myocardial Infarction (>40 days post-AMI) documented with the presence of Q-wave or cardiac-specific enzymatic markers of myocardial necrosis (CK-MB/troponin), occurred within 3 years previous to enrollment / after June 2008.
- Left Ventricular Ejection Fraction (LVEF) ≤40% post-revascularization (if no revascularization, measurement performed <3 months previous to patient enrollment, >40 days post-AMI and >3 months post-revascularization -if applicable-).
Exclusion Criteria:
- Patient with an implanted ICD
- <18 years old
- Pregnant or breast feeding women
- Patients that are already participating in other Investigational Study or Registry
- Non signed patient informed consent or refusal from patient's reference physician to patient participation
- Patient inability to comply with protocol (assist to scheduled follow-ups), due to: residence displacement out of center's activity area; unstable geographical situation or at very long distance from the center; unstable medical and/or psychological condition
- Cardiac transplanted (or in transplant waiting list)
- Severe Heart Failure (or other co-morbidity: cancer, renal failure, etc.)
- Life expectancy lower than 1 year
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 |
|---|---|
|
ICD implantation
Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group
|
Standard ICD implantation (as per clinical decision)
他の名前：
|
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Non ICD implantation
Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g.
antiarrhythmic drugs)
|
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 |
|---|---|---|
|
Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries
時間枠：Patients that suffered from MI in the last 3 years and during the enrollment period
|
Primary Outcome at Stage 1: Determine prevalence of patients with myocardial infarction and high risk of sudden death at Latin America, that fulfill inclusion criteria Primary Outcome at Stage 2: Compare MACE development in patients that receive ICD implantation vs patients that receive other type of treatment (non ICD) |
Patients that suffered from MI in the last 3 years and during the enrollment period
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring
時間枠：5 years (until end 2018)
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5 years (until end 2018)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sergio J Dubner, MD, FACC、Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina
- 主任研究者：William Uribe, MD、CES Cardiología. Medellin, Colombia
- スタディチェア：Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr、Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain
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
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