CARESS in Acute Myocardial Infarction
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00220571
- Lead Sponsor
- Società Italiana di Cardiologia Invasiva
- Brief Summary
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:
* Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
* Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase
- Detailed Description
All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":
- Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
- Previous myocardial infarction (Q- and non Q-wave);
- Killip Class 2 or 3;
- LV ejection fraction at transthoracic ultrasound < 40%.
- Inability to provide informed consent;
- Age > 75 years
- CABG or PCI procedure in past history involving the infarct-related artery;
- Participation in another study with any investigational drug or device within the previous 30 days;
- Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
- Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
- Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
- Severe hepatic disease;
- Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
- Transmural MI in different location within the previous week;
- Previous administration of thrombolytics within 7 days;
- Intolerance or contraindications to ASA or Clopidogrel;
- Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
- Known neutropenia, defined as < 1000 neutrophils / ml;
- Known thrombocytopenia (< 100.000 platelets / ml );
- Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
- Previous hemorrhagic stroke;
- Previous ischemic cerebrovascular event within 3 months;
- Intracranial neoplasm;
- Recent major surgery at risk of bleeding;
- Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
- Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
- Severe recent trauma;
- Known or possible pregnancy;
- Absence of suitable vascular access (diffuse peripheral arterial disease);
- Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study. 30 Day
- Secondary Outcome Measures
Name Time Method Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms; 1 Year Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI 30 Day and 1 Year Compare the incidence of in-hospital stroke and bleeding complications in the two arms. 30 Day
Trial Locations
- Locations (83)
Hesperia Hospital
🇮🇹Modena, Italy
P.O. di Montebelluna
🇮🇹Montebelluna, Italy
Ospedale Civile di Legnano
🇮🇹Legnano, Italy
Ospedale degli Infermi
🇮🇹Rimini, Italy
Oddzialu Kardiologicznego
🇵🇱Dabrowa Gornicza, Poland
Samu - Chu
🇫🇷Grenoble, France
P.O. Cittadella
🇮🇹Cittadella, Italy
P.O. di Cortona
🇮🇹Cortona, Italy
Ospedale Ramazzini
🇮🇹Carpi, Italy
Centre Cardiologique du Nord
🇫🇷St. Denis, France
SMUR Delafontaine
🇫🇷St. Denis, France
Ospedale San Donato
🇮🇹Arezzo, Italy
Spedali Civili
🇮🇹Brescia, Italy
Ospedale S. Sebastiano Martire
🇮🇹Frascati, Italy
Ospedale Cà Foncello
🇮🇹Treviso, Italy
Specjalista Chorob Wewnetryznich
🇵🇱Bedzin, Poland
Oddzial Wewnetrzny - Szpital Mijski w Krynicy
🇵🇱Krynica, Poland
Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej
🇵🇱Limanowa, Poland
Ospedale Bufalini
🇮🇹Cesena, Italy
P.O. di Codogno
🇮🇹Codogno, Italy
Ospedale di Conegliano
🇮🇹Conegliano, Italy
Ospedale S. Giuseppe da Copertino
🇮🇹Copertino, Italy
Ospedale Santa Maria del Prato
🇮🇹Feltre, Italy
Ospedale San Giuliano
🇮🇹Giugliano, Italy
Az. Osp.Vito Fazzi
🇮🇹Lecce, Italy
Fondazione Centro San Raffaele del Monte Tabor IRCCS
🇮🇹Milano, Italy
Azienda Universitaria Federico II
🇮🇹Napoli, Italy
II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie
🇵🇱Jaworzno, Poland
First Dept. Cardiology - Gornoslaskiego Centrum Medycznego
🇵🇱Katovice, Poland
Oddzial Kardiologiczny
🇵🇱Nowy Targ, Poland
Zaklad Opieki Zdrowotnej
🇵🇱Sucha Beskidzka, Poland
A.O. San Camillo
🇮🇹Roma, Italy
Ospedale La Memoria
🇮🇹Gavardo, Italy
Nuovo Ospedale S. Agostino Estense - Baggiovara
🇮🇹Modena, Italy
Ospedale Franchini
🇮🇹Montecchio, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Nuovo Ospedale Civile di Sassuolo
🇮🇹Sassuolo, Italy
Ospedale SS.Annunziata
🇮🇹Savigliano, Italy
Szpital Powiatowy w Chrzanowie
🇵🇱Chrzanow, Poland
Zaklad Hemodynamiki i Angiokardiografii Pracownia 1
🇵🇱Krakow, Poland
Oddzial Wewnetrzny Szpital w Szczyrzu
🇵🇱Szczyrzyc, Poland
Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika
🇵🇱Tarnow, Poland
Szpital Powiatowy im. Jana Pawla II w Wadowicach
🇵🇱Wadowice, Poland
Ospedale S. Eugenio
🇮🇹Roma, Italy
SAMU - Hop. Beaujon
🇫🇷Clichy, France
Ospedale Provinciale di Saronno
🇮🇹Saronno, Italy
Oddzial Wewneztrnj Okregowy Szpital Kolciowy
🇵🇱Katowice, Poland
Ospedale M. Scarlato
🇮🇹Scafati, Italy
Cardiologie - CHU
🇫🇷Grenoble, France
SAMU - Reanimation - CH
🇫🇷Selestat, France
Ospedale S. Sebastiano
🇮🇹cORREGGIO, Italy
Cardiologie Hop. Duffaut
🇫🇷Avignon, France
Cardiologie - Hop. Louis Pradel
🇫🇷Bron, France
Service de Cardiologie - Hopital St. Joseph
🇫🇷Colmar, France
Presidio Ospedaliero del Casentino
🇮🇹Bibbiena, Italy
Az. Ospedaliera di Circolo
🇮🇹Busto Arsizio, Italy
Cardiologie - Hop. Bichat
🇫🇷Paris, France
SAMU - Hop. Duffaut
🇫🇷Avignon, France
Cardiologie - CH
🇫🇷Cherbourg, France
Urgences - CH
🇫🇷Carpentras, France
P.O. di Camposampiero
🇮🇹Camposampiero, Italy
Ospedale Santa Croce e Carle
🇮🇹Cuneo, Italy
Ospedale di Desio
🇮🇹Desio, Italy
Ospedale Santa Caterina Novella
🇮🇹Galatina, Italy
Ospedale di Guastalla
🇮🇹Guastalla, Italy
Ospedale Civile
🇮🇹Riccione, Italy
Ospedale Santa Maria delle Grazie
🇮🇹Pozzuoli, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Ospedale della Valtiberina
🇮🇹Sansepolcro, Italy
Ospedale Magati
🇮🇹Scandiano, Italy
Az. Ospedaliera Galmarini
🇮🇹Tradate, Italy
Oddzialu Chorob Wewnetrznych
🇵🇱Dabrowa Tarnowska, Poland
Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2
🇵🇱Krakow, Poland
Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu
🇵🇱Oswiecim, Poland
Oddzialu Kardiologii z OIOK
🇵🇱Tarnow, Poland
Oddzial Kardiologii - Szpital Powiatowy w Zakopane
🇵🇱Zakopane, Poland
SAMU 69 - Hop. E. Herriot
🇫🇷Lyon, France
Az. Ospedaliera Desenzano sul Garda
🇮🇹Manerbio, Italy
P.O. U.O. Struttura Complessa
🇮🇹San Giovanni Valdarno, Italy
Oddzial Chorob Wewnetrznych
🇵🇱Brzesku, Poland
Oddzial Internistyczno- kardiologiczny
🇵🇱Nowy Sacz, Poland
Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej
🇵🇱Sosnowiec, Poland
Oddzial Kardiologii - Szpital Miejski w Tychach
🇵🇱Tychy, Poland