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Completed

NCT Number: NCT02422316

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

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-contrast Cardiac CT scan

Other

Primary outcomes

  1. major cardiac events

    Time frame: one year

    major cardiac events: cardiac deaths, revascularization, ischaemic related arrythmias, cardiac related readmissions

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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