Clinical trial NCT02828761: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Chest Pain
Keywords: chest pain
calcium score
coronary calcium score
coronary calcium scoring
calcium scoring
cacs
ccs
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 30 days
Secondary outcomes:
measure: Length of Stay
timeFrame: 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:
measure: Subsequent Major Adverse Cardiovascular Events
timeFrame: minimum of 6 months
measure: Repeat emergency department visits and hospitalizations
timeFrame: minimum of 6 months
measure: Subsequent non-invasive cardiac imaging
timeFrame: minimum of 6 months
measure: Subsequent coronary catheterization
timeFrame: minimum of 6 months
measure: Subsequent percutaneous or surgical coronary revascularization
timeFrame: minimum of 6 months
measure: Total effective radiation dose
timeFrame: minimum of 6 months
measure: The number of patients reporting changes in aspirin pharmacotherapy
timeFrame: minimum of 6 months
measure: The number of patients reporting changes in anti-lipid pharmacotherapy
timeFrame: minimum of 6 months
measure: The number of patients reporting persistent chest pain on telephone questionnaire
timeFrame: minimum of 6 months
measure: The number of patients with incidental findings due to imaging and the types of findings
timeFrame: minimum of 6 months
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center - Einstein Division
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Wakefield Division
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Jeffrey M Levsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: