Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients

September 14, 2023 updated by: Montefiore Medical Center

A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - Einstein Division
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Wakefield Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coronary Calcium Scoring
Coronary calcium scoring by multidetector row computed tomography (MDCT).
Device: Coronary Calcium Scoring
Scan with 64-detector row or better CT scanners with quantification by the Agatston method.
Other Names:
  • CCS
  • Calcium Score
  • Calcium Scoring
  • Coronary Calcium Score
  • CACS
Active Comparator: Standard Care
Standard evaluation of chest pain patient which often includes immediate non-invasive imaging.
Procedure: Standard Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 30 days
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
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
emergency department and inpatient
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsequent Major Adverse Cardiovascular Events
Time Frame: minimum of 6 months
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
minimum of 6 months
Repeat emergency department visits and hospitalizations
Time Frame: minimum of 6 months
number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit
minimum of 6 months
Subsequent non-invasive cardiac imaging
Time Frame: minimum of 6 months
number of patients with subsequent stress testing and computed tomography of the heart
minimum of 6 months
Subsequent coronary catheterization
Time Frame: minimum of 6 months
number of patients with subsequent conventional angiography of the heart
minimum of 6 months
Subsequent percutaneous or surgical coronary revascularization
Time Frame: minimum of 6 months
number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery
minimum of 6 months
Total effective radiation dose
Time Frame: minimum of 6 months
effective radiation dose estimated for procedures involving ionizing radiation
minimum of 6 months
The number of patients reporting changes in aspirin pharmacotherapy
Time Frame: minimum of 6 months
patients with new prescriptions for or increased dose of aspirin
minimum of 6 months
The number of patients reporting changes in anti-lipid pharmacotherapy
Time Frame: minimum of 6 months
patients with new prescriptions for or increased dose of lipid lowering medication
minimum of 6 months
The number of patients reporting persistent chest pain on telephone questionnaire
Time Frame: minimum of 6 months
how many patients report continued chest pain symptoms at follow-up
minimum of 6 months
The number of patients with incidental findings due to imaging and the types of findings
Time Frame: minimum of 6 months
how many patients had incidental findings on their heart imaging scans
minimum of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Jeffrey M Levsky, MD, PhD, Montefiore Medical Center/Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

September 14, 2023

Study Completion (Estimated)

September 14, 2023

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimated)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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