NCT02828761

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
7 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

June 15, 2016

Last Update Submit

September 14, 2023

Conditions

Chest Pain

Keywords

chest paincalcium scorecoronary calcium scorecoronary calcium scoringcalcium scoringcacsccs

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events

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

    30 days

Secondary Outcomes (1)

  • 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

Other Outcomes (10)

  • Subsequent Major Adverse Cardiovascular Events

    minimum of 6 months

  • Repeat emergency department visits and hospitalizations

    minimum of 6 months

  • Subsequent non-invasive cardiac imaging

    minimum of 6 months

  • +7 more other outcomes

Study Arms (2)

Coronary Calcium Scoring

EXPERIMENTAL

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

Device: Coronary Calcium Scoring

Standard Care

ACTIVE COMPARATOR

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

Procedure: Standard Care

Interventions

Coronary Calcium ScoringDEVICE

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

Also known as: Calcium Score, Calcium Scoring, Coronary Calcium Score, CACS, CCS
Coronary Calcium Scoring
Standard CarePROCEDURE

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.

Standard Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • complaint of chest pain or pressure
  • intermediate risk by HEART score
  • clinical indication for non-invasive cardiac imaging
  • free of known coronary artery disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center - Einstein Division

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Wakefield Division

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Chest Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jeffrey M Levsky, MD, PhD

    Montefiore Medical Center/Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 12, 2016

Study Start

July 1, 2023

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)