Screening for Pregnancy Related Heart Failure in Nigeria

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05438576

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), National Institutes of Health (NIH) (NIH)

1,000

Enrollment

Locations

Arms

15.5

Anticipated Duration (Months)

166.7

Patients Per Site

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy Pregnancy Related	Other: Artificial Intelligence enabled electrocardiogram (AI-ECG)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants will have ECGs analyzed with artificial intelligence for cardiomyopathy detection.	Other: Artificial Intelligence enabled electrocardiogram (AI-ECG) An artificial intelligence algorithm which analyses 12-lead ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.
No Intervention: Control Participants will have standard clinical ECGs acquired.

Arm

Intervention/Treatment

Experimental: Intervention

Participants will have ECGs analyzed with artificial intelligence for cardiomyopathy detection.

Other: Artificial Intelligence enabled electrocardiogram (AI-ECG)

An artificial intelligence algorithm which analyses 12-lead ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.

No Intervention: Control

Participants will have standard clinical ECGs acquired.

Outcome Measures

Primary Outcome Measures

Left Ventricular Ejection Fraction (LVEF) <50% [18 months]
Number of participants diagnosed with left ventricular ejection fraction (LVEF) <50% by echocardiography during pregnancy or within 12 months postpartum.

Secondary Outcome Measures

All-Cause Mortality [18 months]
Total number of deaths from all causes among participants
Adverse Cardiovascular Events [18 months]
Number of adverse cardiovascular events including cardiomyopathy or systolic heart failure, diastolic heart failure, hypertensive disorders of pregnancy, preeclampsia/eclampsia, valvular heart disease, heart failure-related hospitalization, sustained ventricular arrhythmias, resuscitated cardiac arrest, and other pregnancy-related complications.
Left Ventricular Ejection Fraction (LVEF) <45% [18 months]
Number of participants diagnosed with left ventricular ejection fraction (LVEF) <45% by echocardiography during pregnancy or within 12 months postpartum.
Left Ventricular Ejection Fraction (LVEF) <40% [18 months]
Number of participants diagnosed with left ventricular ejection fraction (LVEF) <40% by echocardiography during pregnancy or within 12 months postpartum.
Left Ventricular Ejection Fraction (LVEF) ≤35% [18 months]
Number of participants diagnosed with left ventricular ejection fraction (LVEF) ≤35% by echocardiography during pregnancy or within 12 months postpartum
Echocardiography utilization [18 months]
Number of echocardiograms obtained in the intervention group compared to the control

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Rasheed Shekoni Specialist Hospital	Dutse	Jigawa	Nigeria
2	University of Ilorin Teaching Hospital	Ilorin	Kwara	Nigeria
3	Olabisi Onabanjo University Teaching Hospital	Sagamu	Ogun	Nigeria
4	University College Hospital	Ibadan	Oyo	Nigeria
5	Aminu Kano Teaching Hospital	Kano		Nigeria
6	Lagos University Teaching Hospital	Lagos		Nigeria