Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

NCT ID: NCT01413282

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.

Detailed Description

Myocardial infarction remains one of the most important causes of death and disability. Therefore it is important that individuals with acute chest pain are accurately assessed without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden chest pain, which is a very common complaint in the ER. Other life threatening causes such as pulmonary embolism and aortic dissection may also be the cause, although most chest discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc).

The current work-up of suspected acute coronary syndrome, based on presentation, symptoms, ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital admissions, as well as errors or delayed diagnoses, in a substantial number of patients. Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and allows for accurate and immediate triage of patients with acute chest pain.

Conditions

Acute Coronary Syndrome; Acute Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiac CT

Triage based on cardiac CT results.

Group Type: ACTIVE_COMPARATOR

Cardiac CT

Intervention Type: RADIATION

Calcium scan and CT coronary angiography

Standard Care

Standard diagnostic management according to the European guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardiac CT

Calcium scan and CT coronary angiography

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Acute chest pain or equivalent
• Patients older than 30 years
• Males < 75 years and Females < 80 years

Exclusion Criteria

• STEMI
• Troponin > 0.1
• History of known myocardial infarction, PCI or CABG
• Pregnancy
• Contrast allergy
• Renal disfunction
• No informed consent possible
• No follow-up possible

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Koen Nieman

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koen Nieman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

References

Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.

Reference Type: DERIVED

PMID: 26764061 (View on PubMed)

Other Identifiers

BEACON-11

Identifier Type: -

Identifier Source: org_study_id