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Clinical Trials/NCT02828761
NCT02828761
Withdrawn
Not Applicable

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

Montefiore Medical Center2 sites in 1 countryJuly 2023
ConditionsChest Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chest Pain
Sponsor
Montefiore Medical Center
Locations
2
Primary Endpoint
Major Adverse Cardiovascular Events
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
September 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events

Time Frame: 30 days

number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest

Secondary Outcomes

  • Length of Stay(through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days)

Study Sites (2)

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