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

NCT ID: NCT02828761

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2023-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Coronary Calcium Scoring

Coronary calcium scoring by multidetector row computed tomography (MDCT).

Group Type EXPERIMENTAL

Coronary Calcium Scoring

Intervention Type DEVICE

Scan with 64-detector row or better CT scanners with quantification by the Agatston method.

Standard Care

Standard evaluation of chest pain patient which often includes immediate non-invasive imaging.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type PROCEDURE

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.

Interventions

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Coronary Calcium Scoring

Scan with 64-detector row or better CT scanners with quantification by the Agatston method.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Calcium Score Calcium Scoring Coronary Calcium Score CACS CCS

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey M Levsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

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Montefiore Medical Center - Einstein Division

The Bronx, New York, United States

Site Status

Montefiore Medical Center - Wakefield Division

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2015-4993

Identifier Type: -

Identifier Source: org_study_id

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