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NCT04983875 · ClinicalTrials.gov registry record · NA
Mammography and Breast Arterial Calcification: An Information-Sharing Trial
A NA study of Mammography and Vascular Calcification, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 5,708
- Enrollment target
- 1
- Study location
NCT04983875: Recruiting NA study of Mammography and Vascular Calcification, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04983875 is a NA study of Mammography and Vascular Calcification that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 5,708 participants, above the 2,593-participant average among 3 other Mammography trials with a reported enrollment target (120% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04983875, a NA study of Mammography and Vascular Calcification, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 5,708 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, representative group of 5708 women. Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 508 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.
Primary Outcome
Patients will be asked a YES/NO question asking them to report whether they have seen a healthcare provider to talk about their heart or coronary artery disease in the last six months. Patient's self-report responses will be confirmed via medical record review.
Conditions Studied
Interventions
- BEHAVIORAL BAC-Enhanced Letter
- BEHAVIORAL Waitlist Control
Study Locations (1)
New York
- Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,708 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT04983875 shows while recruiting
NCT04983875 is an interventional study that assigns participants to a tested intervention. Its 5,708 participants enrollment target places it among the larger protocols in the corpus, above the 2,593-participant average among 3 other Mammography trials with a reported enrollment target (120% higher).
The record links to 2 conditions, with Mammography appearing as the primary indexed condition, and to 2 interventions - of which BAC-Enhanced Letter is the first listed.
NCT04983875 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04983875 about?
NCT04983875 is a clinical study titled "Mammography and Breast Arterial Calcification: An Information-Sharing Trial". The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms ...
What is the current status of trial NCT04983875?
This trial is currently recruiting. It is a NA study. The enrollment target is 5,708 participants. The study started on 2021-09-29. Estimated completion is 2027-03-31.
What conditions does trial NCT04983875 study?
This clinical trial studies the following conditions: Mammography, Vascular Calcification.
What interventions are being tested in trial NCT04983875?
The interventions under investigation include: BAC-Enhanced Letter (BEHAVIORAL), Waitlist Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04983875?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04983875 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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