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Cardiac-CT in the Treatment of Acute Chest Pain (CATCH)

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cardiac computed tomographic angiography (CCTA)
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring Cardiac CT, Ischemic heat disease, Stress test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CT guided group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiac death
myocardial infarction
readmissions for chest pain
Revascularisation
unstabile angina
continued chest pain
Quality of life (SF-36)
medication
non-cardiac findings on CT
downstream testing

Full Information

First Posted
December 22, 2011
Last Updated
June 18, 2014
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01534000
Brief Title
Cardiac-CT in the Treatment of Acute Chest Pain
Acronym
CATCH
Official Title
Cardiac-CT in the Treatment of Acute Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Cardiac CT, Ischemic heat disease, Stress test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT guided group
Arm Type
Active Comparator
Arm Description
For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cardiac computed tomographic angiography (CCTA)
Other Intervention Name(s)
Adenosin for CT myocardial perfusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
1 year follow-up
Title
myocardial infarction
Time Frame
1 year follow-up
Title
readmissions for chest pain
Time Frame
1 year follow-up
Title
Revascularisation
Time Frame
1 year follow-up
Title
unstabile angina
Time Frame
1-year follow-up
Title
continued chest pain
Time Frame
1 year follow-up
Title
Quality of life (SF-36)
Time Frame
1-year follow-up
Title
medication
Time Frame
1-year follow-up
Title
non-cardiac findings on CT
Time Frame
1-year follow-up
Title
downstream testing
Time Frame
1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper J Linde, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26577263
Citation
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.
Results Reference
derived

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Cardiac-CT in the Treatment of Acute Chest Pain

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