Cardiac-CT in the Treatment of Acute Chest Pain

Ischemic Heart Disease Clinical Trial

— CATCH  

Official title:

Cardiac-CT in the Treatment of Acute Chest Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534000
• Other study ID #: H-C-2009-053
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: June 18, 2014
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.

Methods:

Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).

After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admittance because of Chest pain

• Non- or non-diagnostic ecg-changes.

• Normal biomarkers for ischemia (Troponins)

• Chest X-ray without pathological findings associated with chest pain.

Exclusion Criteria:

• Women of childbearing age, or > 40 years and using approved contraception.

• Claustrophobia

• Patients with geographical residence, that complicates follow-up

• Patients with mental or physical conditions that impede follow-up

• Increase in Troponins

• New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion> 4 mm in> 2 anatomically connected derivations.

• Allergy to iodinated contrast agents

• Serum creatinine greater than 130 mg/l

• Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Cardiac computed tomographic angiography (CCTA)
Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain		1 year follow-up	No
Secondary	Cardiac death		1 year follow-up	No
Secondary	myocardial infarction		1 year follow-up	No
Secondary	readmissions for chest pain		1 year follow-up	No
Secondary	Revascularisation		1 year follow-up	No
Secondary	unstabile angina		1-year follow-up	No
Secondary	continued chest pain		1 year follow-up	No
Secondary	Quality of life (SF-36)		1-year follow-up	No
Secondary	medication		1-year follow-up	No
Secondary	non-cardiac findings on CT		1-year follow-up	No
Secondary	downstream testing		1-year follow-up	No