Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 35
- Primary Endpoint
- Sensitivity of point of care cardiac ultrasound for the detection of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram.
Study Overview
Brief Summary
The purpose of this study is to develop a pilot screening protocol, comparing cardiac point-of-care ultrasound (POCUS), electrocardiogram (EKG), serum biomarkers (N-terminal pro b-type natriuretic peptide (NT-proBNP), high sensitivity troponin (hsTn)) with formal transthoracic echocardiogram (TTE) in pregnant women with methamphetamine use.
Detailed Description
This is a pilot study that examines previously undiagnosed cardiac pathology utilizing transthoracic echocardiogram (TTE) in pregnant women with chronic methamphetamine use and assesses possible screening modalities (cardiac point-of-care ultrasound (POCUS), serum biomarkers, electrocardiogram (EKG)) in identifying underlying disease in this population. As this is a prospective observational study, we will assess pregnancy-related complications and care connections in the pilot tertiary academic setting.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older > 20 weeks gestation admitted to the hospital
- •Active patient-defined regular methamphetamine use for at least 1 year and any use within the last month
- •Able to understand and provide informed consent
- •Able to understand English
Exclusion Criteria
- •These criteria will exclude women whose medications, personal traits, obstetric conditions, or diseases could confound cardiovascular risk.
- •Prescribed stimulants
- •Echocardiogram or EKG previously performed during current pregnancy
- •Previous diagnosis of congestive heart dysfunction
- •Previous diagnosis of pulmonary hypertension
- •Previous myocardial infarction
- •Previous diagnosis of endocarditis
- •Prior cardiac intervention (repair of cardiac congenital lesion, valve replacement or repairs, percutaneous/operative treatment of arrhythmias)
- •High-risk aortopathy (Marfan syndrome, bicuspid aortopathy, prior aortic dissection)
Outcomes
Primary Outcomes
Sensitivity of point of care cardiac ultrasound for the detection of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram.
Time Frame: Day 1
This outcome seeks to identify the sensitivity of point of care cardiac ultrasound for the identification of left ventricular systolic dysfunction in pregnant people who use methamphetamine when performed by an obstetrics provider, as compared to formal transthoracic echocardiogram.
Secondary Outcomes
- Sensitivity of cardiac biomarkers and ECG for the identification of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram. methamphetamine(Day 1)
- Prevalence of underlying structural heart disease in pregnant people who use methamphetamine(Day 1)
- Pregnancy and delivery outcomes in people who use methamphetamine(3 months postpartum)
- Changes to pregnancy-related treatment plan based on cardiovascular screening in people who use methamphetamine.(3 months postpartum)
Investigators
Evan Shalen
Assistant Professor
Oregon Health and Science University