NCT07309757

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 16, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Methamphetamine usePregnancyCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of point of care cardiac ultrasound for the detection of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram.

    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.

    Day 1

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women \> or equal to 20 weeks gestation presenting to OHSU for hospital, day patient, or observation admission will be identified via the electronic medical record.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Evan Shalen, MD

CONTACT

Sara McCrimmon

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share