Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Methamphetamine Abuse. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Sensitivity of cardiac biomarkers and ECG for the identification of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram. methamphetamine [Time frame: Day 1]
- Prevalence of underlying structural heart disease in pregnant people who use methamphetamine [Time frame: Day 1]
- Pregnancy and delivery outcomes in people who use methamphetamine [Time frame: 3 months postpartum]
- Changes to pregnancy-related treatment plan based on cardiovascular screening in people who use methamphetamine. [Time frame: 3 months postpartum]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07309757 · STUDY00028946