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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03588286




Registration number
NCT03588286
Ethics application status
Date submitted
4/07/2018
Date registered
17/07/2018
Date last updated
7/05/2024

Titles & IDs
Public title
Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)
Scientific title
Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)
Secondary ID [1] 0 0
ACTRN12614000042640
Secondary ID [2] 0 0
PROTECT-ICD, Version 5
Universal Trial Number (UTN)
Trial acronym
PROTECT-ICD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Cardiac Death 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Electrophysiology study (EPS)
Other interventions - Standard Care
Treatment: Surgery - Cardiac Magnetic Resonance (CMR)

Experimental: Intervention Arm (Early EPS) - The intervention group all undergo electrophysiologic study early after myocardial infarction (within 40 days of MI).

If the study is positive (inducible monomorphic ventricular tachycardia of cycle length greater than or equal to 200ms) participants have an ICD implanted. Participants with a negative study (no inducible arrhythmia or induced ventricular fibrillation/ ventricular flutter cycle length \<200ms) are discharged without an ICD.

A proportion of trial patients from both the intervention and control arms at \>48 hours following revascularisation for STEMI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. CMR will simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury.

Active comparator: Control Arm (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).

A proportion of trial patients from both the intervention and control arms at \>48 hours following revascularisation for STEMI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. CMR will simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury.


Treatment: Surgery: 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.

Other interventions: 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).

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sudden cardiac death
Timepoint [1] 0 0
2 years after randomisation
Primary outcome [2] 0 0
Non-fatal arrhythmia
Timepoint [2] 0 0
2 years after randomisation
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
2 years after randomisation
Secondary outcome [2] 0 0
Non-sudden cardiovascular death
Timepoint [2] 0 0
2 years after randomisation
Secondary outcome [3] 0 0
Non-fatal repeat MI
Timepoint [3] 0 0
2 years after randomisation
Secondary outcome [4] 0 0
Heart failure
Timepoint [4] 0 0
2 years after randomisation
Secondary outcome [5] 0 0
Inappropriate ICD denial
Timepoint [5] 0 0
2 years after randomisation
Secondary outcome [6] 0 0
Appropriate ICD activations (in patients with ICD)
Timepoint [6] 0 0
2 years after randomisation
Secondary outcome [7] 0 0
Inappropriate ICD activations (in patients with ICD)
Timepoint [7] 0 0
2 years after randomisation
Secondary outcome [8] 0 0
Complications or re-hospitalisation associated with ICD implantation (in patients with ICD)
Timepoint [8] 0 0
2 years after randomisation

Eligibility
Key inclusion criteria
* 2-40 days (inclusive) following a myocardial infarct
* Impaired left ventricular systolic function (LVEF=40% or at least moderately impaired)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <18 or >85;
2. Pregnancy;
3. Nursing home resident dependent on one or more activities of daily living;
4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease);
5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;
6. Intravenous drug abuse (ongoing);
7. Unresolved infection associated with risk for hematogenous seeding;
8. Pre-existing implantable cardioverter-defibrillator (ICD);
9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring =48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded));
10. On the heart transplant list;
11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);**
12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)** **NOTE: patients who meet exclusion based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for inclusion.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/12/2029
Actual
Sample size
Target
1058
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [8] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [9] 0 0
Carins Hospital - Cairns
Recruitment hospital [10] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [11] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [12] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [13] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [15] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [16] 0 0
MonashHeart - Clayton
Recruitment hospital [17] 0 0
Northern Hospital - Epping
Recruitment hospital [18] 0 0
Austin Hospital - Melbourne
Recruitment hospital [19] 0 0
Western Health, Sunshine and Footscray Hospitals - Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4575 - Birtinya
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4032 - Chermside
Recruitment postcode(s) [11] 0 0
4814 - Douglas
Recruitment postcode(s) [12] 0 0
4029 - Herston
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment postcode(s) [14] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [15] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [16] 0 0
3168 - Clayton
Recruitment postcode(s) [17] 0 0
3076 - Epping
Recruitment postcode(s) [18] 0 0
3084 - Melbourne
Recruitment postcode(s) [19] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Neustadt An Der Saale
Country [4] 0 0
Germany
State/province [4] 0 0
Brandenburg
Country [5] 0 0
Germany
State/province [5] 0 0
Göttingen
Country [6] 0 0
Germany
State/province [6] 0 0
Leipzig
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Iraklio
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Hungary
State/province [10] 0 0
Debrecen
Country [11] 0 0
Hungary
State/province [11] 0 0
Pécs
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem
Country [13] 0 0
Latvia
State/province [13] 0 0
Riga
Country [14] 0 0
Malaysia
State/province [14] 0 0
Kuala Lumpur
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Hamilton
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
New Zealand
State/province [18] 0 0
Wellington
Country [19] 0 0
Poland
State/province [19] 0 0
Warszawa
Country [20] 0 0
Poland
State/province [20] 0 0
Lódz
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Saint Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Samara
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
Slovakia
State/province [24] 0 0
Bratislava
Country [25] 0 0
Switzerland
State/province [25] 0 0
Basel
Country [26] 0 0
Switzerland
State/province [26] 0 0
Bern
Country [27] 0 0
Switzerland
State/province [27] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Principal Investigator Study Principal Investigator
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pramesh Kovoor
Address 0 0
Country 0 0
Phone 0 0
+61 2 8890 6030
Fax 0 0
Email 0 0
pramesh.kovoor@sydney.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03588286