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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens D Hove, MD,PHD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01534000
First received: December 22, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Procedure: Cardiac computed tomographic angiography (CCTA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiac-CT in the Treatment of Acute Chest Pain

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
  • readmissions for chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
  • Revascularisation [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
  • unstabile angina [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • continued chest pain [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
  • Quality of life (SF-36) [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • medication [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • non-cardiac findings on CT [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • downstream testing [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: January 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
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.
Other Name: Adenosin for CT myocardial perfusion
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534000

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Jesper J Linde, MD Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Jens D Hove, MD,PHD, Chief of Cardiac CT, MD,PHD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01534000     History of Changes
Other Study ID Numbers: H-C-2009-053
Study First Received: December 22, 2011
Last Updated: June 18, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Cardiac CT
Ischemic heat disease
Stress test

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014