- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07809932
Breast Artery Calcification (BAC) and Female Cardiovascular Disease
Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Previous work has demonstrated an association between incidentally found BAC on screening mammograms and long-term major adverse cardiovascular events. However, there are no guidelines for how to manage asymptomatic women with no history of cardiovascular disease who have incidentally found BAC on a screening mammogram. This study will simulate a reasonable approach that a cardiologist might take in determining how to manage such patients. The study is unique compared with prior studies that have utilized a convenience sample, the investigators seek to gather this information in two parallel cohorts prospectively.
The investigators seek to recruit 100 women with BAC = 0 and 100 women with BAC >0 on their mammograms. The inclusion and exclusion criteria for these groups is otherwise identical. All women have had a recent mammogram and are 55-65 years old. Exclusion criteria include: ischemia, diabetes, statin/cholesterol lowering medication use, cardiovascular disease, breast cancer, breast surgery, current pregnancy/breastfeeding, and women unable to consent.
Participants will be recruited over the phone and able to e-consent if interested in the study. All participants will fill out 2 questionnaires: one on their baseline demographics/clinical history, and one on social factors. Patients will then be scheduled for bloodwork at a Northwell lab which will need to be done in a fasting state. Patients will also be schedules for a Cardiac CT scan performed at the hospital. All costs will be paid for by the study itself and patients will receive no bills from these exams.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Thara Ali, MD
- Numéro de téléphone: 917-951-8945
- E-mail: Tali7@northwell.edu
Sauvegarde des contacts de l'étude
- Nom: Elizabeth M Musso, BA
- Numéro de téléphone: 516-881-7012
- E-mail: emusso1@northwell.edu
Lieux d'étude
-
-
New York
-
Manhasset, New York, États-Unis, 11030
- Recrutement
- North Shore University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- female
- 55-65 years old
Exclusion Criteria:
- ischemia
- diabetes
- statin or cholesterol lowering medicine use
- cardiovascular disease: coronary artery disease, heart failure, arrhythmia, significant valvular disease
- history of breast surgery or breast cancer
- pregnant women
- breastfeeding women
- women unable to consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
BAC = 0 Group
|
A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
Blood will be drawn at a Northwell Lab.
Participants will need to fast before the collection.
Cholesterol levels, blood sugar (hemoglobin A1C), and markers for inflammation and kidney function will be analyzed.
|
|
BAC >0 Group
|
A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
Blood will be drawn at a Northwell Lab.
Participants will need to fast before the collection.
Cholesterol levels, blood sugar (hemoglobin A1C), and markers for inflammation and kidney function will be analyzed.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Coronary Artery Calcium Score
Délai: 7 days
|
This result is obtained by the Cardiac CT Scan.
|
7 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Dyslipidemia
Délai: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
High-sensitivity C-reactive protein elevation
Délai: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
Lp(a) elevation
Délai: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
HbA1c
Délai: 3 days
|
Obtained through laboratory testing
|
3 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nisha Parikh, MD, MPH, Northwell Health
Publications et liens utiles
Publications générales
- Wilmot KA, O'Flaherty M, Capewell S, Ford ES, Vaccarino V. Coronary Heart Disease Mortality Declines in the United States From 1979 Through 2011: Evidence for Stagnation in Young Adults, Especially Women. Circulation. 2015 Sep 15;132(11):997-1002. doi: 10.1161/CIRCULATIONAHA.115.015293. Epub 2015 Aug 24.
- Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.
- Monticciolo DL, Malak SF, Friedewald SM, Eby PR, Newell MS, Moy L, Destounis S, Leung JWT, Hendrick RE, Smetherman D. Breast Cancer Screening Recommendations Inclusive of All Women at Average Risk: Update from the ACR and Society of Breast Imaging. J Am Coll Radiol. 2021 Sep;18(9):1280-1288. doi: 10.1016/j.jacr.2021.04.021. Epub 2021 Jun 19.
- Venkatesan P. New US breast cancer screening recommendations. Lancet Oncol. 2023 Jun;24(6):e242. doi: 10.1016/S1470-2045(23)00238-3. Epub 2023 May 18. No abstract available.
- Koh TJW, Tan HJH, Ravi PRJ, Sng JWZ, Yeo TC, Tan BYQ, Chai P, Yeo LLL, Chan MY, Kong WKF, Wong RCC, Teo YH, Ho JSY, Teo YN, Sia CH. Association Between Breast Arterial Calcifications and Cardiovascular Disease: A Systematic Review and Meta-analysis. Can J Cardiol. 2023 Dec;39(12):1941-1950. doi: 10.1016/j.cjca.2023.07.024. Epub 2023 Jul 26.
- Bui QM, Daniels LB. A Review of the Role of Breast Arterial Calcification for Cardiovascular Risk Stratification in Women. Circulation. 2019 Feb 19;139(8):1094-1101. doi: 10.1161/CIRCULATIONAHA.118.038092.
- Bots SH, Peters SAE, Woodward M. Sex differences in coronary heart disease and stroke mortality: a global assessment of the effect of ageing between 1980 and 2010. BMJ Glob Health. 2017 Mar 27;2(2):e000298. doi: 10.1136/bmjgh-2017-000298. eCollection 2017.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 25-0239
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .