Cardiovascular Risk Assessment in Young Women After Index Pregnancy With and Without Placental Complications

NCT07356817 | Recruiting

• 1 other identifier: IIBSP-MOM-2022-87
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, the investigators aim to study how all these factors determine the cardiovascular status of a total of 1,800 mothers, 3 to 6 years after delivery. In addition, the investigators want to assess whether lifestyle and living conditions after childbirth may improve or worsen this imprint, since women often prioritize their families over themselves, making it more difficult to maintain a healthy lifestyle that could reduce their cardiovascular risk. Furthermore, the investigators will evaluate how environmental exposures influence their health, as well as explore potential strategies for prediction and prevention. The goal is to develop an easy-to-use algorithm or test that allows women and their physicians to assess this risk, ideally in the form of a mobile app. Although predictive algorithms for cardiovascular health already exist, most have been developed using predominantly male or older populations, and none have taken into account pregnancy-related events or environmental exposure - both of which are key determinants of women's cardiovascular health.

Conditions

Cardiovascular (CV) Risk; Preeclampsia (PE); Fetal Weight

Keywords

preeclampsia; Cardiovascular Risk; app

Outcome Measures

Primary Outcomes (5)

• Hypertension

  Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg)

  3-6 years after index pregnancy

• Abnormal cardiac function

  Abnormal cardiac function in the echocardiographic ultrasound assessment. Abnormal values of the different parameters will be considered according to reference limits published in 2020 by the British Society of Echocardiography

  3-6 years after index pregnancy

• Biochemical cardiac markers

  Abnormal biochemical cardiac markers: NTproBNP \>300 ng/L or high-sensitivity troponin\>30 ng/L

  3-6 years after index pregnancy

• Coronary artery disease

  Signs of coronary artery disease by computer tomography (CCT) myocardial perfusion imaging (mild (CACS≥10 AU and \<100 AU); moderate (CACS≥100 AU and \<400 AU) and severe (CACS ≥400 AU)

  3-6 years after index pregnancy

• Other cardiovascular major events

  Cardiovascular major events (ictus, coronary artery disease, cardiac insufficiency or myocardiopathy)

  3-6 years after index pregnancy

Secondary Outcomes (45)

• Age

  3-6 years after index pregnancy

• Pregnancy complications

  3-6 years after index pregnancy

• Antrophometric measurements

  3-6 years after index pregnancy

• Blood pressure

  3-6 years after index pregnancy

• Computer tomography (CCT) myocardial perfusion imaging and RM Quantitative Myocardial Perfusion

  3-6 years after index pregnancy

Study Arms (1)

Young women with an index pregnancy with and without placental complications

CV biophysical, imaging and biochemical variables 3-6 years after index pregnancy (approximate n=1260) will be evaluated. Analyses will include urbanome, placental function and perinatal variables during index pregnancy and postnatal variables such as maternal socio-economic status, lifestyle, urban exposome, mental health, blood pressure, cardiac function, coronary artery disease by Coronary Computed Tomography (CCT) and CCT angiography, RM Quantitative Myocardial Perfusion, ophthalmic artery index, carotid intima- media thickness up to 6 years after delivery to predict higher risk for CVD later in life. Patients' needs and expectations according to CV health would be evaluated.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young women who presented an index pregnancy with and without placental complications, who have previously participated in cohort studies performed by our group identifying biophysical, biochemical, psychosocial and environmental cardiovascular risk factors during pregnancy

You may qualify if:

• Patients who participated in the BiSC (Barcelona Life Study Cohort), EuroPE (Randomized open-label control trial to evaluate if the incorporation of sFlt1/PlGF ratio in the diagnosis and classification of PE improves maternal and perinatal outcomes in women with suspicion of the disease; PI16/00375) and AngioCor (Cardiac dysfunction and remodeling in patients with preeclampsia regulated by antiangiogenic environment: clinical and experimental approach, PI19/00702) cohort studies
• Who have delivered within the previous 3-6 years.
• Give written consent when invited to participate in this study protocol.

You may not qualify if:

• Unwillingness to participate in this study
• Probability of loss to follow-up.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Hospital Sant Joan de Deu: collaborator
• Barcelona Institute for Global Health: collaborator

Study Sites (1)

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (5)

• Brotons C, Moral I, Fernandez D, Puig M, Calvo Bonacho E, Martinez Munoz P, Catalina Romero C, Quevedo Aguado LJ. Estimation of Lifetime Risk of Cardiovascular Disease (IBERLIFERISK): A New Tool for Cardiovascular Disease Prevention in Primary Care. Rev Esp Cardiol (Engl Ed). 2019 Jul;72(7):562-568. doi: 10.1016/j.rec.2018.05.028. Epub 2018 Aug 7. English, Spanish.

  PMID: 30097396 BACKGROUND

• Ferencik M, Pencina KM, Liu T, Ghemigian K, Baltrusaitis K, Massaro JM, D'Agostino RB Sr, O'Donnell CJ, Hoffmann U. Coronary Artery Calcium Distribution Is an Independent Predictor of Incident Major Coronary Heart Disease Events: Results From the Framingham Heart Study. Circ Cardiovasc Imaging. 2017 Oct;10(10):e006592. doi: 10.1161/CIRCIMAGING.117.006592.

  PMID: 28956774 BACKGROUND

• Saenger AK, Beyrau R, Braun S, Cooray R, Dolci A, Freidank H, Giannitsis E, Gustafson S, Handy B, Katus H, Melanson SE, Panteghini M, Venge P, Zorn M, Jarolim P, Bruton D, Jarausch J, Jaffe AS. Multicenter analytical evaluation of a high-sensitivity troponin T assay. Clin Chim Acta. 2011 Apr 11;412(9-10):748-54. doi: 10.1016/j.cca.2010.12.034. Epub 2011 Jan 8.

  PMID: 21219893 BACKGROUND

• Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.

  PMID: 16293638 BACKGROUND

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

  PMID: 29146535 BACKGROUND

Related Links

• IBERLIFERISK score
• REGICOR questionnaire
• Phisycal activity questionnaire

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine and hair samples

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Weight; Alzheimer Disease

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elisa Llurba, PhD

  Hospital de la Sant Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Llurba Olivé, PhD

CONTACT

+34 935534078; ellurba@santpau.cat

Pablo García Manau, PhD

CONTACT

+34 627813346; pgarciama@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 21, 2026
• Study Start: August 28, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

ES (1)