Prediction of ARrhythmic Events With Positron Emission Tomography II (NCT03493516) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prediction of ARrhythmic Events With Positron Emission Tomography II
United States302 participantsStarted 2018-04-08
Plain-language summary
Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
* ICD implantation for the primary prevention of SCA
* Primary prevention patients with a Biventricular ICD
* Eligible immediately when this is placed to prevent dysynchrony related to intermittent RV pacing and the native QRS duration is ≤ 130 msec in the absence of pacing.
* Eligible 6 months after implantation when the native QRS duration prior to implant is \>130 msec or there is persistent RV pacing.
* Optimal medical therapy for heart failure.
Exclusion Criteria:
* Plans for coronary revascularization (due to the independent impact on SCA)
* Contraindication for PET (i.e. claustrophobia, pregnancy, physical limitation)
* Tricyclic antidepressant use (inhibits norepinephrine and LMI1195 uptake)
* Comorbidities limiting life expectancy \<2yr.
* Age \<18 years or inability to provide informed consent
* Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sudden Cardiac Arrest Events
Timeframe: Through study completion, an average of 3 years