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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02828761
• Other study ID #: 2015-4993
• Status: Withdrawn
• Phase: N/A
• Start date: July 2023
• Est. completion date: September 14, 2023

Study information

• Verified date: September 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Emergencies

Intervention

Device:
• Coronary Calcium Scoring
Scan with 64-detector row or better CT scanners with quantification by the Agatston method.

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Einstein Division	Bronx	New York
United States	Montefiore Medical Center - Wakefield Division	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subsequent Major Adverse Cardiovascular Events	number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest	minimum of 6 months
Other	Repeat emergency department visits and hospitalizations	number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit	minimum of 6 months
Other	Subsequent non-invasive cardiac imaging	number of patients with subsequent stress testing and computed tomography of the heart	minimum of 6 months
Other	Subsequent coronary catheterization	number of patients with subsequent conventional angiography of the heart	minimum of 6 months
Other	Subsequent percutaneous or surgical coronary revascularization	number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery	minimum of 6 months
Other	Total effective radiation dose	effective radiation dose estimated for procedures involving ionizing radiation	minimum of 6 months
Other	The number of patients reporting changes in aspirin pharmacotherapy	patients with new prescriptions for or increased dose of aspirin	minimum of 6 months
Other	The number of patients reporting changes in anti-lipid pharmacotherapy	patients with new prescriptions for or increased dose of lipid lowering medication	minimum of 6 months
Other	The number of patients reporting persistent chest pain on telephone questionnaire	how many patients report continued chest pain symptoms at follow-up	minimum of 6 months
Other	The number of patients with incidental findings due to imaging and the types of findings	how many patients had incidental findings on their heart imaging scans	minimum of 6 months
Primary	Major Adverse Cardiovascular Events	number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest	30 days
Secondary	Length of Stay	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