1,058
Participants
Start Date
February 27, 2014
Primary Completion Date
December 6, 2027
Study Completion Date
December 6, 2029
Electrophysiology study (EPS)
EPS will be performed in all patients in the intervention arm with programmed ventricular stimulation with a drive train of 8 beats at 400 ms with up to 4 extrastimuli and stimulation from the right ventricular apex with current delivered at twice pacing threshold. The end point for stimulation will be sustained monomorphic ventricular tachycardia (VT) lasting \> 10 seconds. If sustained monomorphic VT with cycle length (CL) ≥200ms is induced by ≤4 extra stimuli the EPS result will be considered positive for inducible VT.30 Ventricular fibrillation or flutter with CL\<200ms will be considered a negative result. The Programmed Ventricular Stimulation (PVS) induction will be repeated a second time if the initial induction was negative for VT.
Standard Care
The control group receive ongoing standard care according to the practise of their institution. This includes discharge from hospital as per their treating physician and follow up as usual in the community. Participants in this group would be eligible to receive an ICD according to the standard practise of their cardiologist (guideline recommendations are after 40 days following myocardial infarction or 90 days following revascularisation only in patients with left ventricular ejection fraction less than or equal to 30% or less than or equal to 35% in the presence of heart failure).
Cardiac Magnetic Resonance (CMR)
CMR will be performed on either a 1.5-T or 3-T scanner. Gadolinium contrast (Gd-BOPTA, MultihanceTM) will be administered for quantification myocardial perfusion imaging with subsequent late gadolinium enhanced imaging after a total dose of 0.1mmol/kg. Exclusion criteria specific for CMR will include pregnancy, renal insufficiency defined as glomerular filtration rate (GFR) \<30 mL/min, contraindication to MRI (including non-MRI compatible pacemaker/ICD or metal implants, non-MR safe prosthetic heart valves), claustrophobia which cannot be controlled via standard methods (benzodiazepines and/or sedative antihistamine administration) and prior allergic reaction to gadolinium-based contrast agent.
WITHDRAWN
Auckland City Hospital, Grafton
WITHDRAWN
Middlemore Hospital, Otahuhu
RECRUITING
Prince of Wales Hospital, Randwick
RECRUITING
Royal North Shore Hospital, Saint Leonards
RECRUITING
Westmead Hospital, Westmead
RECRUITING
John Hunter Hospital, New Lambton Heights
RECRUITING
Wollongong Hospital, Wollongong
RECRUITING
Canberra Hospital, Garran
RECRUITING
Nepean Hospital, Kingswood
RECRUITING
Wellington Hospital, Wellington
RECRUITING
University Hospital Bern, Bern
WITHDRAWN
Northern Hospital, Epping
TERMINATED
Austin Hospital, Melbourne
COMPLETED
MonashHeart, Clayton
RECRUITING
Waikato Hospital, Hamilton W.
RECRUITING
Royal Brisbane and Women's Hospital, Herston
RECRUITING
University Hospital Basel, Basel
RECRUITING
The Prince Charles Hospital, Chermside
RECRUITING
Princess Alexandra Hospital, Woolloongabba
RECRUITING
Gold Coast University Hospital, Southport
RECRUITING
Sunshine Coast University Hospital, Birtinya
RECRUITING
The Townsville Hospital, Douglas
RECRUITING
Carins Hospital, Cairns
RECRUITING
Lyell McEwin Hospital, Elizabeth Vale
RECRUITING
Institut Jantung Negara Sdn Bhd, Kuala Lumpur
RECRUITING
National University Heart Centre, Singapore (NUHCS), Singapore
NOT_YET_RECRUITING
Beth Israel Deaconess Medical Center, Boston
WITHDRAWN
Western Health, Sunshine and Footscray Hospitals, Melbourne
NOT_YET_RECRUITING
Institute for Clinical and Experimental Medicine, Prague
RECRUITING
Cardiovascular Center Bad Neustadt, Bad Neustadt an der Saale
RECRUITING
Klinikum Brandenburg, Brandenburg
ACTIVE_NOT_RECRUITING
Universitaetsmedizin Gittingen (University of Göttingen Medical Center), Göttingen
ACTIVE_NOT_RECRUITING
Leipzig Heart Center, Leipzig
NOT_YET_RECRUITING
Universitätsklinikum Leipzig, Leipzig
ACTIVE_NOT_RECRUITING
General Hospital of Athens Giorgios Gennimatas, Athens
ACTIVE_NOT_RECRUITING
General Hospital of Athens Ippokrateio, Athens
NOT_YET_RECRUITING
University Hospital of Heraklion Crete, Heraklion
RECRUITING
Semmelweis University Heart and Vascular Center, Budapest
RECRUITING
University of Debrecen, Debrecen
RECRUITING
University of Pécs, Pécs
RECRUITING
Sharee Zadek Medical Centre, Jerusalem
RECRUITING
Paul Stradins University Clinic, Riga
RECRUITING
Pusat Jantung Sarawak (PJS)(Sarawak Heart Centre), Kuala Lumpur
RECRUITING
Christchurch Hospital, Christchurch
RECRUITING
Medical University of Łódź - Biegański Provincial Specialist Hospital, Lodz
RECRUITING
Medical University of Łódź - WAM Hospital, Lodz
RECRUITING
Medical University of Łódź, Lodz
NOT_YET_RECRUITING
National Institute of Cardiology Warsaw, Warsaw
NOT_YET_RECRUITING
Almazov National Medical Research Centre, Saint Petersburg
WITHDRAWN
Samara State Medical University, Samara
NOT_YET_RECRUITING
The National Institute of Cardiovascular Diseases, Bratislava
WITHDRAWN
Lausanne University Hospital, Lausanne
Western Sydney Local Health District
OTHER