Cardiac-CT in the Treatment of Acute Chest Pain

NCT ID: NCT01534000

Last Updated: 2014-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-01-31

Brief 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.

Conditions

Ischemic Heart Disease

Study Design

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

Study Groups

CT guided group

For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA)

Group Type: ACTIVE_COMPARATOR

Cardiac computed tomographic angiography (CCTA)

Intervention Type: PROCEDURE

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.

Control group

Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography). A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Adenosin for CT myocardial perfusion

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jens D Hove, MD,PHD

Chief of Cardiac CT, MD,PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesper J Linde, MD

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

References

Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.

Reference Type: DERIVED

PMID: 26577263 (View on PubMed)

Other Identifiers

H-C-2009-053

Identifier Type: -

Identifier Source: org_study_id