Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:33 AM
Study NCT ID:
NCT07309757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of point of care cardiac ultrasound for the detection of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram.', 'timeFrame': 'Day 1', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of cardiac biomarkers and ECG for the identification of left ventricular systolic dysfunction as compared to comprehensive transthoracic echocardiogram. methamphetamine', 'timeFrame': 'Day 1', 'description': 'This outcome seeks to identify the sensitivity of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitivity troponin and electrocardiogram for the identification of left ventricular systolic dysfunction in pregnant people who use methamphetamine, as compared to formal transthoracic echocardiogram.'}, {'measure': 'Prevalence of underlying structural heart disease in pregnant people who use methamphetamine', 'timeFrame': 'Day 1', 'description': 'This outcome seeks to identify the prevalence of structural heart disease in pregnant people who use methamphetamine.'}, {'measure': 'Pregnancy and delivery outcomes in people who use methamphetamine', 'timeFrame': '3 months postpartum', 'description': 'This outcome seeks to identify the prevalence of pregnancy delivery complications in people who use methamphetamine.'}, {'measure': 'Changes to pregnancy-related treatment plan based on cardiovascular screening in people who use methamphetamine.', 'timeFrame': '3 months postpartum', 'description': 'This outcome seeks to identify linkage to cardiovascular and addiction specialty care among patients diagnosed with cardiovascular disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methamphetamine use', 'Pregnancy', 'Cardiomyopathy'], 'conditions': ['Methamphetamine Abuse']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older \\> 20 weeks gestation admitted to the hospital\n* Active patient-defined regular methamphetamine use for at least 1 year and any use within the last month\n* Able to understand and provide informed consent\n* Able to understand English\n\nExclusion Criteria:\n\nThese criteria will exclude women whose medications, personal traits, obstetric conditions, or diseases could confound cardiovascular risk.\n\n* Prescribed stimulants\n* Echocardiogram or EKG previously performed during current pregnancy\n* Previous diagnosis of congestive heart dysfunction\n* Previous diagnosis of pulmonary hypertension\n* Previous myocardial infarction\n* Previous diagnosis of endocarditis\n* Prior cardiac intervention (repair of cardiac congenital lesion, valve replacement or repairs, percutaneous/operative treatment of arrhythmias)\n* High-risk aortopathy (Marfan syndrome, bicuspid aortopathy, prior aortic dissection)'}, 'identificationModule': {'nctId': 'NCT07309757', 'briefTitle': 'Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Maternal Outcomes With Methamphetamine Use and Cardiac Assessment for Rural Dissemination (MOM CARD)', 'orgStudyIdInfo': {'id': 'STUDY00028946'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Evan Shalen, MD', 'role': 'CONTACT', 'email': 'shalen@ohsu.edu', 'phone': '503-494-1775'}, {'name': 'Sara McCrimmon', 'role': 'CONTACT', 'email': 'mccrimmo@ohsu.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Evan Shalen', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}