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SPIRIT-ICD
Sponsor study identifier
interventional
504
11 countries
37
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
July 2014
Actual (reported)The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients. This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 11, 2008
Actual (reported)February 21, 2008
Actual (reported)April 2014
Actual (reported)July 2014
Actual (reported)Mortality
12 months
Sudden cardiac death
12 months
Non-sudden cardiac death
12 months
Risk of 1st heart failure hospitalization
12 months
Standard follow-up in patients without appropriate ICD therapy
Following 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy.
* Assessment of general health status (weight, BP, NYHA) * Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15) * Echocardiography (LVEF, LVEDD, mitral regurgitation) * Non-invasive ischemia evaluation * Coronary angiography (if indicated by ischemia evaluation) * Upgrade to CRT, if indicated * Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry) * 24 hrs ECG Holter (Heart rate variability) * Further treatment (if applicable) * Changes in ICD settings, or medication
A.ö. Krankenhaus der Stadt Linz
Linz, 4020, Austria
Landesklinikum St. Pölten
Sankt Pölten, 3100, Austria
Wilhelminenspital der Stadt Wien
Vienna, 1160, Austria
Brno Bohunice
Brno, 62500, Czechia
Fakultni nemocnice u Svety Anny
Brno, 65691, Czechia
FN Olomouc, Inerni klinika
Olomouc, 77520, Czechia
Online 24 S.R.O.
Prague, 12000, Czechia
Robert Hatala, Prof. MUDr.
Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia
504 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2008
First Posted
February 21, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
No. of VT Storms (> 3 VT/24h)
12 months
No. of delivered ICD therapies
12 months
Standard follow-up in patients without appropriate ICD therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Institute of clinical and experimental medicine
Prague, 1421, Czechia
University Hospital RWTH Aachen
Aachen, 52074, Germany
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, 97616, Germany
Klinikum Bielefeld
Bielefeld, 33604, Germany
Universitätsklinikum Bonn
Bonn, 53105, Germany
St. Marien Hospital
Bonn, 53115, Germany
Klinikum Detmold Lippe
Detmold, 32756, Germany
Klinikum Mitte
Dortmund, 44137, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, 01067, Germany
Evangelisches Krankenhaus
Düsseldorf, 40217, Germany
Hermann-Josef-Krankenhaus
Erkelenz, 41812, Germany
Justus Liebig Universität Gießen
Giessen, 35392, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Krankenhaus Landshut-Achdorf
Landshut, 84034, Germany
Krankenhaus St. Franziskus
Mönchengladbach, 41063, Germany
St. Vincenz Krankenhaus
Paderborn, 33098, Germany
University Hospital Rostock
Rostock, 18055, Germany
Katharinenhospital
Unna, 59423, Germany
Semmelweis University
Budapest, 1122, Hungary
The University of Medicine Debrecen
Debrecen, 4012, Hungary
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Latvian Center of Cardiology
Riga, 1002, Latvia
Health Waikato, Cardiology Department
Hamilton, New Zealand
MULTI-MED PLUS Spolka z o.o
Lodz, 95336, Poland
Instytut Kardiologii
Warzawa, 04-628, Poland
Ssusch
Banská Bystrica, 97401, Slovakia
Kardiologická klinika
Bratislava, 833 48, Slovakia
VUSCH East Slovak Cardiology Institute
Košice, 04001, Slovakia
H. Univ. La Fe
Valencia, 46009, Spain
Universitätsspital Basel
Basel, 4031, Switzerland
Primary Completion
April 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
January 12, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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