NCT02591992

Brief Summary

To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with a high probability of stable coronary artery disease according to European Society of Cardiology recommendations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

October 27, 2015

Last Update Submit

February 17, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • The average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority)

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • The proportion of "avoidable" invasive diagnostic procedures (coronary angiographies not followed by an intervention) in the arm: A. Angio-CT versus B. Classic diagnostics (superiority)

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • Composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization, hospitalization for cardiovascular reason, stroke

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

Secondary Outcomes (8)

  • composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease

    up to 36 months (through study completion)

  • Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke

    up to 36 months (through study completion)

  • Number of angioplasty procedures performed in accordance with ESC recommendations where the treatment planned on the basis of CT angiography by an interventional cardiologist is not treated ad-hoc.

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • Average number of therapeutic procedures (PCI/CABG).

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • +3 more secondary outcomes

Other Outcomes (2)

  • The volume of contrast agent used for diagnosis and possible coronary intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority)

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

  • The radiation dose used for diagnosis of coronary artery disease and possible intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority)

    up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).

Study Arms (2)

Cardiac CT

ACTIVE COMPARATOR

60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo computed tomography angiography (cardiac CT) as the first-choice imaging diagnostics

Other: Cardiac CT as the first diagnostic modality in suspected CAD

Invasive coronary angiography

ACTIVE COMPARATOR

60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography

Other: Invasive coronary angiography as indicated by the guidelines

Interventions

Cardiac CT as the first diagnostic modality in suspected CADOTHER

Performation of non-invasive cardiac CT angiogram

Cardiac CT
Invasive coronary angiography as indicated by the guidelinesOTHER

Patient undergoes invasive coronary angiography

Invasive coronary angiography

Eligibility Criteria

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

You may qualify if:

  • Age \>18 years
  • Patients providing written informed consent
  • Indications for elective invasive coronary angiography defined by European Society of Cardiology as:
  • Left ventricle ejection fraction \<50% and typical angina symptoms,
  • Probability of coronary artery disease due to criteria of age, sex and symptoms \>85%, or
  • Probability of coronary artery disease due to criteria of age, sex and symptoms 50-85% with positive or moderate cardiac stress test.

You may not qualify if:

  • No Consent to the study
  • Acute coronary syndrome
  • Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization,
  • Contraindications to invasive coronary angiography
  • GFR \<60 ml/min/1.73m2
  • Significant arrhythmia
  • BMI \>35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

RECRUITING

Related Publications (1)

  • Rudzinski PN, Kruk M, Kepka C, Schoepf UJ, Duguay T, Dzielinska Z, Pregowski J, Witkowski A, Ruzyllo W, Demkow M. The value of Coronary Artery computed Tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected Coronary Artery Disease: CAT-CAD randomized trial. J Cardiovasc Comput Tomogr. 2018 Nov-Dec;12(6):472-479. doi: 10.1016/j.jcct.2018.08.004. Epub 2018 Sep 4.

    PMID: 30201310DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mariusz Kruk, Prof.

    National Institute of Cardiology, Warsaw, Poland

    STUDY CHAIR

Central Study Contacts

Piotr N Rudziński, M.D.

CONTACT

+48608499737piotr.rudzinski@ikard.pl

Mariusz Kruk, Prof.

CONTACT

+48223434342mkruk@ikard.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2018

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

PL(1)