Health TrialsbyHealthPanel

The PICM Risk Prediction Study - Application of AI to Pacing

ConditionsHeart FailurePacemaker-Induced CardiomyopathyPacemaker Complication
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality. At present a lack of data leads to a failure to identify patients who are at risk of PICM and would benefit from pre-selection to physiological pacing. In the light of the foregoing, there is an urgent need for novel non-invasive detection techniques which would aid risk stratification, offer a better understanding of the prevalence and incidence of PICM in individuals with pacing devices and the contribution of additional risk factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients who received a pacing device (VVI, DDD, ICD, leadless pacemaker) from the GSTT/RBH/KCH/ICH database in the last 10 years (from 01/01/2014)

All patients who are >18 years old.

Male and Female

Disqualifiers

Patients who did not receive a pacing device (VVI, DDD, ICD, leadless pacemaker)

All patients <18 years old

Patients with congenital heart disease

Patients who have received artificial heart valves or underwent cardiac bypass surgery

Trial population

All patients who received a pacemaker at GSTT and RBH in the last 10 years and all patients who received a pacemaker at KCH and ICH in the last 3 years.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Machine learning

    Other intervention

    Analysis of data with machine learning methods

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Pacing induced cardiomyopathy1 intervention
Group B: Non-pacing induced cardiomyopathy1 intervention

Trial outcomes

Primary outcomes

1

Primary aim

Number of risk factors in participants who developed pacing induced cardiomyopathy

Time frame
2.5 years

Secondary outcomes

1

Secondary aim

1\. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the prevalence of pacemaker induced cardiomyopathy (PICM)

Time frame
2.5 years
2

Tertiary aim

2\. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the incidence of PCIM 2. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the incidence of PCIM

Time frame
2.5 years
3

Quarternary aim

3.• To establish mortality of PICM

Time frame
2.5 years
4

Quinary aim

4\. To establish the morbidity of PICM

Time frame
2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator

King's College Hospital NHS Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: