NCT01534000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

December 22, 2011

Last Update Submit

June 18, 2014

Conditions

Keywords

Cardiac CTIschemic heat diseaseStress test

Outcome Measures

Primary Outcomes (1)

  • combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain

    1 year follow-up

Secondary Outcomes (10)

  • Cardiac death

    1 year follow-up

  • myocardial infarction

    1 year follow-up

  • readmissions for chest pain

    1 year follow-up

  • Revascularisation

    1 year follow-up

  • unstabile angina

    1-year follow-up

  • +5 more secondary outcomes

Study Arms (2)

CT guided group

ACTIVE COMPARATOR

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

Procedure: Cardiac computed tomographic angiography (CCTA)

Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Adenosin for CT myocardial perfusion
CT guided group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Jesper J Linde, MD

    Hvidovre University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiac CT, MD,PHD

Study Record Dates

First Submitted

December 22, 2011

First Posted

February 16, 2012

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations