Back to resultsCoronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
Primary Purpose
Chest Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary Calcium Scoring
Standard Care
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs
Eligibility Criteria
Inclusion Criteria:
- complaint of chest pain or pressure
- intermediate risk by HEART score
- clinical indication for non-invasive cardiac imaging
- free of known coronary artery disease
Exclusion Criteria:
- hemodynamic instability
- electrocardiogram suggestive of acute ischemia or myocardial infarction
- unremitting chest pain
- serum troponin levels greater than three times the laboratory threshold
- unable to give his/her own written, informed consent
- pregnant women
- weight > 182 kg
- unable to lie supine for scan
- coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review
- unable to comply with 30 day follow-up
Sites / Locations
- Montefiore Medical Center - Einstein Division
- Montefiore Medical Center - Wakefield Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coronary Calcium Scoring
Standard Care
Arm Description
Coronary calcium scoring by multidetector row computed tomography (MDCT).
Standard evaluation of chest pain patient which often includes immediate non-invasive imaging.
Outcomes
Primary Outcome Measures
Major Adverse Cardiovascular Events
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
Secondary Outcome Measures
Length of Stay
emergency department and inpatient
Full Information
NCT ID
NCT02828761
First Posted
June 15, 2016
Last Updated
September 14, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02828761
Brief Title
Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
Official Title
A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study never initiated and formally withdrawn with the IRB on 9/14/2023.
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
September 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary Calcium Scoring
Arm Type
Experimental
Arm Description
Coronary calcium scoring by multidetector row computed tomography (MDCT).
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard evaluation of chest pain patient which often includes immediate non-invasive imaging.
Intervention Type
Device
Intervention Name(s)
Coronary Calcium Scoring
Other Intervention Name(s)
Calcium Score, Calcium Scoring, Coronary Calcium Score, CACS, CCS
Intervention Description
Scan with 64-detector row or better CT scanners with quantification by the Agatston method.
Intervention Type
Procedure
Intervention Name(s)
Standard Care
Intervention Description
Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Length of Stay
Description
emergency department and inpatient
Time Frame
through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days
Other Pre-specified Outcome Measures:
Title
Subsequent Major Adverse Cardiovascular Events
Description
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
Time Frame
minimum of 6 months
Title
Repeat emergency department visits and hospitalizations
Description
number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit
Time Frame
minimum of 6 months
Title
Subsequent non-invasive cardiac imaging
Description
number of patients with subsequent stress testing and computed tomography of the heart
Time Frame
minimum of 6 months
Title
Subsequent coronary catheterization
Description
number of patients with subsequent conventional angiography of the heart
Time Frame
minimum of 6 months
Title
Subsequent percutaneous or surgical coronary revascularization
Description
number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery
Time Frame
minimum of 6 months
Title
Total effective radiation dose
Description
effective radiation dose estimated for procedures involving ionizing radiation
Time Frame
minimum of 6 months
Title
The number of patients reporting changes in aspirin pharmacotherapy
Description
patients with new prescriptions for or increased dose of aspirin
Time Frame
minimum of 6 months
Title
The number of patients reporting changes in anti-lipid pharmacotherapy
Description
patients with new prescriptions for or increased dose of lipid lowering medication
Time Frame
minimum of 6 months
Title
The number of patients reporting persistent chest pain on telephone questionnaire
Description
how many patients report continued chest pain symptoms at follow-up
Time Frame
minimum of 6 months
Title
The number of patients with incidental findings due to imaging and the types of findings
Description
how many patients had incidental findings on their heart imaging scans
Time Frame
minimum of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
complaint of chest pain or pressure
intermediate risk by HEART score
clinical indication for non-invasive cardiac imaging
free of known coronary artery disease
Exclusion Criteria:
hemodynamic instability
electrocardiogram suggestive of acute ischemia or myocardial infarction
unremitting chest pain
serum troponin levels greater than three times the laboratory threshold
unable to give his/her own written, informed consent
pregnant women
weight > 182 kg
unable to lie supine for scan
coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review
unable to comply with 30 day follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Levsky, MD, PhD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center - Einstein Division
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center - Wakefield Division
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
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