Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422316
• Other study ID #: SHS-ED-2014-01
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: February 16, 2016
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Background:

Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction. However, several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population. Not all of these patients can be identified by traditional risk factors such as cholesterol, hypertension, and diabetes or with conventional methods such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group. The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal.

Methods:

The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation. 750 patients, age 30-70 years who are included in the study: "Identification of risk factors in non-cardiac chest pain patients" will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact. The participants will be included in a 12 months follow up, where the result of the calcium score is not revealed neither for the patient nor the investigator. After 12 months the results of the scan is compared with the rate of cardiac events. This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark.

The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• chest pain with normal cardiac enzymes.

• legal competent

• age 30-70 years

Exclusion Criteria:

• chest pain of obvious reason

• previous acute coronary syndrome

• previous coronary artery investigations within last five years

• patients referred for other cardiac examinations after the current admission

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Non-contrast Cardiac CT scan

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major cardiac events	major cardiac events: cardiac deaths, revascularization, ischaemic related arrythmias, cardiac related readmissions	one year	No