- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Thara Ali, MD
- Telefonnummer: 917-951-8945
- E-post: Tali7@northwell.edu
Studera Kontakt Backup
- Namn: Elizabeth M Musso, BA
- Telefonnummer: 516-881-7012
- E-post: emusso1@northwell.edu
Studieorter
-
-
New York
-
Manhasset, New York, Förenta staterna, 11030
- Rekrytering
- North Shore University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Coronary Artery Calcium Score
Tidsram: 7 days
|
This result is obtained by the Cardiac CT Scan.
|
7 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Dyslipidemia
Tidsram: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
High-sensitivity C-reactive protein elevation
Tidsram: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
Lp(a) elevation
Tidsram: 3 days
|
Obtained through laboratory testing
|
3 days
|
|
HbA1c
Tidsram: 3 days
|
Obtained through laboratory testing
|
3 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nisha Parikh, MD, MPH, Northwell Health
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 25-0239
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