The PICM Risk Prediction Study - Application of AI to Pacing

June 5, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

Predictive Risk Algorithm for Development of Right Ventricular Pacing Induced Cardiomyopathy - a Step Towards Personalized Pacemaker Lead Deployment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Retrospective review of patient characteristics including 12 lead resting electrocardiograms and imaging data (CMR, CT, echo, CXR and fluoroscopy of pacing leads) of patients with right sided ventricular pacing lead due to symptomatic bradycardia, who developed pacing induced cardiomyopathy (or need for CRT upgrade) versus patients who did not using supervised machine learning methods. Development of personalised predictive pacing algorithm to improve right ventricular lead placement, such as conduction system pacing or pre-emptive implantation of an additional left ventricular lead to prevent left ventricular dilatation and pacemaker-induced cardiomyopathy (PICM) with heart failure (left ventricular ejection fraction <50% by Simpson method), hospitalisation or death with the use of the retrospective patient data through machine learning.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients who did not have an echocardiogram after receiving a pacing device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pacing induced cardiomyopathy
Patients who received a pacing device and developed pacing induced cardiomyopathy
Other: Machine learning
Analysis of data with machine learning methods
Non-pacing induced cardiomyopathy
Patients who received a pacing device and did not develop pacing induced cardiomyopathy
Other: Machine learning
Analysis of data with machine learning methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary aim
Time Frame: 2.5 years
Number of risk factors in participants who developed pacing induced cardiomyopathy
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary aim
Time Frame: 2.5 years
1. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the prevalence of pacemaker induced cardiomyopathy (PICM)
2.5 years
Tertiary aim
Time Frame: 2.5 years
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
2.5 years
Quarternary aim
Time Frame: 2.5 years
3.• To establish mortality of PICM
2.5 years
Quinary aim
Time Frame: 2.5 years
4. To establish the morbidity of PICM
2.5 years
Senary aims
Time Frame: 2.5 years
5.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of right ventricular lead position or leadless pacemaker position
2.5 years
Septenary aim
Time Frame: 2.5 years
6.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of myocardial pathology from echocardiogram and cardiac MRI
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College Hospital NHS Trust
Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 333705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Machine learning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe