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Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT) (SUSPECT)

Primary Purpose

Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CT Angiography
Exercise stress test
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coronary Artery Disease (CAD)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Military aircrew of the Royal Netherlands Air Force
  • ≥ 40 years old
  • Required to undergo cardiac screening (per military aviation regulations)

Exclusion Criteria:

  • Typical angina
  • Prior myocardial infarction
  • Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG))
  • Left ventricular ejection fraction <35%
  • Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures

  • CT-related contra-indications

    • Allergic to iodine contrast.
    • Renal insufficiency (GFR <60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd_gfr_si.
    • Severe claustrophobia.
    • Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade
    • Pregnancy

Sites / Locations

  • Center for Man in Aviation
  • Utrecht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CT Angiography

Exercise stress test

Arm Description

Coronary CT Angiography will be performed on all individuals

An bicycle exercise stress test will be performed on all individuals

Outcomes

Primary Outcome Measures

Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool

Secondary Outcome Measures

Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA
Both modalities are used to track down clinically relevant CAD. Clinically relevant CAD is defined as a stenosis of >50%.
Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months
Compare the incidence of coronary angiograms and revascularization procedures in the population screened with CTA compared to a historical population using CTA as a secondary screening tool
Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA

Full Information

First Posted
August 9, 2022
Last Updated
August 23, 2022
Sponsor
UMC Utrecht
Collaborators
Center for Man in Aviation, Royal Netherlands Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT05508893
Brief Title
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
Acronym
SUSPECT
Official Title
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding stopped
Study Start Date
November 17, 2014 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Center for Man in Aviation, Royal Netherlands Air Force

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force. All asymptomatic aircrew (≥40 years) are asked to undergo a coronary CT scan on a voluntary basis, following the exercise electrocardiograms performed at their routine aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases, Aviator's; Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every participant will perform an exercise test and receive a CTA afterwards
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT Angiography
Arm Type
Other
Arm Description
Coronary CT Angiography will be performed on all individuals
Arm Title
Exercise stress test
Arm Type
Other
Arm Description
An bicycle exercise stress test will be performed on all individuals
Intervention Type
Radiation
Intervention Name(s)
CT Angiography
Intervention Description
A CTA will be performed on asymptomatic individuals
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise stress test
Intervention Description
A routine exercise stress test will be performed on a bicycle
Primary Outcome Measure Information:
Title
Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
Time Frame
8 Years
Secondary Outcome Measure Information:
Title
Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA
Description
Both modalities are used to track down clinically relevant CAD. Clinically relevant CAD is defined as a stenosis of >50%.
Time Frame
8 Years
Title
Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months
Time Frame
8 Years
Title
Compare the incidence of coronary angiograms and revascularization procedures in the population screened with CTA compared to a historical population using CTA as a secondary screening tool
Time Frame
8 Years
Title
Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA
Time Frame
8 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Military aircrew of the Royal Netherlands Air Force ≥ 40 years old Required to undergo cardiac screening (per military aviation regulations) Exclusion Criteria: Typical angina Prior myocardial infarction Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG)) Left ventricular ejection fraction <35% Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures CT-related contra-indications Allergic to iodine contrast. Renal insufficiency (GFR <60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd_gfr_si. Severe claustrophobia. Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Nathoe, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Frijters
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Man in Aviation
City
Soesterberg
State/Province
Utrecht
ZIP/Postal Code
3769 DE
Country
Netherlands
Facility Name
Utrecht University Medical Center
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)

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