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Clinical Trials/NCT05438576
NCT05438576
Completed
Not Applicable

Screening for Peripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) in Nigeria

Mayo Clinic6 sites in 1 country1,232 target enrollmentAugust 15, 2022
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ConditionsCardiomyopathyPregnancy Related

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy
Sponsor
Mayo Clinic
Enrollment
1232
Locations
6
Primary Endpoint
Left Ventricular Ejection Fraction (LVEF) <50%
Status
Completed
Last Updated
11 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
May 15, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Demilade A. Adedinsewo

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • •Currently pregnant or within 12 months postpartum
  • •Willing and able to provide informed consent

Exclusion Criteria

  • •Complex congenital heart disease (single ventricle physiology or significant shunts with cardiac structural changes)
  • •Significant conduction abnormalities (ventricular pacing on recorded ECG, pacemaker dependence, or severely abnormal/bizarre QRS morphology on ECG tracings)
  • •Unable or unwilling to provide consent

Outcomes

Primary Outcomes

Left Ventricular Ejection Fraction (LVEF) <50%

Time Frame: 18 months

Number of participants diagnosed with left ventricular ejection fraction (LVEF) \<50% by echocardiography during pregnancy or within 12 months postpartum.

Secondary Outcomes

  • Effectiveness of AI-ECG for Cardiomyopathy Detection in the Intervention Arm for Left Ventricular Ejection Fraction (LVEF) ≤ 35%(18 months)
  • Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 40%(18 months)
  • Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 45%(18 months)
  • Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 50%(18 months)

Study Sites (6)

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