Skip to main content
OpenTrials
Completed

NCT Number: NCT02014311

CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion

The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.

The following main hypothesis will be tested:

- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Copenhagen, Denmark

Loading trial locations.

About this study

MATERIAL

  • Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.

METHODS

-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent acute-onset chest pain where coronary artery disease is suspected
  • During initial acute hospitalization:
  • Normal coronary biomarkers (Troponins)
  • No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
  • Age ≥50 years
  • ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%

Exclusion criteria

  • Known Iodine contrast allergy
  • Estimated GFR below 50 ml/min
  • Adenosine intolerance - known allergic asthma
  • Previous CABG
  • Patient related circumstances which preclude informed consent from the patient
  • Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
  • Expected survival of less that 2 years

Treatment and study plan

CTA+CTP guided treatment strategy

Procedure

CTA+CTP guided treatment strategy

CTA guided treatment strategy

Procedure

CTA guided treatment strategy

Primary outcomes

  1. Frequency of coronary revascularization among included patients referred for invasive investigation

    Time frame: Within 60 days of study inclusion

    Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded

Secondary outcomes

  1. Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death

    Time frame: Within 3, 12 and 24 months after CT examination

  2. New referral for invasive investigation following inititial evaluation

    Time frame: 3, 12 and 24 months after CT examination

  3. Coronary revascularization - not including revascularization related to index evaluation

    Time frame: 3, 12 and 24 months after CT examination

  4. Invasive procedure related events

    Time frame: Within 30 days of invasive procedure

    Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Amager Hospital
  • Bispebjerg Hospital
  • Copenhagen University Hospital, Hvidovre
  • Glostrup University Hospital, Copenhagen
  • Herlev Hospital
  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial

Acronym: CATCH2

Important dates

Study start
2013
Primary completion
2017
Study completion
2022
First posted
Dec 18, 2013
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.