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Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients (FAST-CCTA)

Primary Purpose

Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Coronary computed tomopraphic angiography
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain

Eligibility Criteria

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

Inclusion Criteria:

  1. Age≥18 years.
  2. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
  3. HEART-score >3 (according to http://www.heartscore.nl/)
  4. Written informed consent obtained

Exclusion Criteria:

  1. Any condition that may influence the patient's ability to comply with study protocol.
  2. Acute MI
  3. Known obstructive CAD (>50%) or previous PCI or CABG.
  4. Clear alternative diagnosis
  5. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  6. Major allergy to iodinated contrast media
  7. Circumstances making high quality images unlikely.
  8. Not a Swedish resident with a personal ID-number.
  9. Pregnancy or breast feeding
  10. Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
  11. Previous inclusion in the trial

Sites / Locations

  • Danderyd HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coronary computed tomopraphic angiography

No Coronary computed tomopraphic angiography

Arm Description

Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and referred to a CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days. Local scanning protocols can be used on ≥64-slice multi-detector CT scanners able to perform ECG-gated coronary angiography. The coronary angiography will be classified as normal (or near normal) or as having atherosclerosis (CAD). The report will also classify each vessel (left main, prox LAD, mid or distal LAD, LCX and RCA regarding degree of stenosis (no stenosis, 0-49%, ≥50%, or not possible to estimate because of calcification or technical reason). The result will be presented to the responsible physician as soon as possible and who will plan further care of the patients.

Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always. Regardless of diagnostic strategy, the responsible physician is encouraged to initiate secondary prevention measures if the investigations indicate signs of CAD, including medication with aspirin and statins.

Outcomes

Primary Outcome Measures

The composite of death, readmission because of MI or unstable angina requiring revascularization
death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event

Secondary Outcome Measures

Death or readmission because MI
death of any cause, readmission because of MI (I21)
Death
death of any cause
Cardiovascular death
death because of cardiovascular cause (I00-99)
MI (fatal or non-fatal)
readmission because of MI or death because of MI (I21)
Readmission because of unstable angina requiring revascularization
revascularization because of unstable angina not related to the index event.
Death, readmission because MI or stroke
death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Stroke (fatal or non-fatal)
readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
Resource use / Health care costs
Hospitalizations and investigations
Re-presentation to the ED because of chest pain
Re-presentation with chest pain as the main complaint
Invasive coronary angiography
Any invasive coronary angiography
Non-obstructive CAD at first invasive coronary angiography
Invasive coronary angiography without any significant stenoses
Angina
at least grade 1 according to Rose questionnaire
Use of prevention medications
Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Health-related quality of life
RAND-36: 8 domains/scales

Full Information

First Posted
January 29, 2021
Last Updated
October 7, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04748237
Brief Title
Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients
Acronym
FAST-CCTA
Official Title
Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

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

5. Study Description

Brief Summary
The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.
Detailed Description
Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score >3) will after written informed consent be randomized to either a strategy with an initial CCTA or not. Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 7 days).The result will be presented to the responsible physician who will plan further care of the patients. Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always. All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD. The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization at 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score >3) will after written informed consent be randomized to either a strategy with an initial coronary computed tomographic angiography or not.
Masking
Outcomes Assessor
Masking Description
Before adjudication, all documents will be masked regarding previous coronary computed tomographic angiography.
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary computed tomopraphic angiography
Arm Type
Experimental
Arm Description
Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and referred to a CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days. Local scanning protocols can be used on ≥64-slice multi-detector CT scanners able to perform ECG-gated coronary angiography. The coronary angiography will be classified as normal (or near normal) or as having atherosclerosis (CAD). The report will also classify each vessel (left main, prox LAD, mid or distal LAD, LCX and RCA regarding degree of stenosis (no stenosis, 0-49%, ≥50%, or not possible to estimate because of calcification or technical reason). The result will be presented to the responsible physician as soon as possible and who will plan further care of the patients.
Arm Title
No Coronary computed tomopraphic angiography
Arm Type
No Intervention
Arm Description
Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always. Regardless of diagnostic strategy, the responsible physician is encouraged to initiate secondary prevention measures if the investigations indicate signs of CAD, including medication with aspirin and statins.
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary computed tomopraphic angiography
Intervention Description
CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days.
Primary Outcome Measure Information:
Title
The composite of death, readmission because of MI or unstable angina requiring revascularization
Description
death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event
Time Frame
at 3 years
Secondary Outcome Measure Information:
Title
Death or readmission because MI
Description
death of any cause, readmission because of MI (I21)
Time Frame
3 years
Title
Death
Description
death of any cause
Time Frame
3 years
Title
Cardiovascular death
Description
death because of cardiovascular cause (I00-99)
Time Frame
3 years
Title
MI (fatal or non-fatal)
Description
readmission because of MI or death because of MI (I21)
Time Frame
3 years
Title
Readmission because of unstable angina requiring revascularization
Description
revascularization because of unstable angina not related to the index event.
Time Frame
3 years
Title
Death, readmission because MI or stroke
Description
death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Time Frame
3 years
Title
Stroke (fatal or non-fatal)
Description
readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
Time Frame
3 years
Title
Resource use / Health care costs
Description
Hospitalizations and investigations
Time Frame
3 years
Title
Re-presentation to the ED because of chest pain
Description
Re-presentation with chest pain as the main complaint
Time Frame
3 years
Title
Invasive coronary angiography
Description
Any invasive coronary angiography
Time Frame
3 years
Title
Non-obstructive CAD at first invasive coronary angiography
Description
Invasive coronary angiography without any significant stenoses
Time Frame
3 years
Title
Angina
Description
at least grade 1 according to Rose questionnaire
Time Frame
1 year
Title
Use of prevention medications
Description
Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Time Frame
1, 2 and 3 years
Title
Health-related quality of life
Description
RAND-36: 8 domains/scales
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD) HEART-score >3 (according to http://www.heartscore.nl/) Written informed consent obtained Exclusion Criteria: Any condition that may influence the patient's ability to comply with study protocol. Acute MI Known obstructive CAD (>50%) or previous PCI or CABG. Clear alternative diagnosis Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 Major allergy to iodinated contrast media Circumstances making high quality images unlikely. Not a Swedish resident with a personal ID-number. Pregnancy or breast feeding Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status Previous inclusion in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liselotte Persson, RN
Phone
+46812355000
Email
Liselotte.Persson@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Löfmark, MD
Email
Henrik.Lofmark@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Jernberg, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Löfmark, MD
Email
henrik.lofmark@sll.se
First Name & Middle Initial & Last Name & Degree
Liselotte Persson, RN
Email
liselotte.persson@sll.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can, after completion of study and the first report, apply for making analyses in collaboration with the steering group.

Learn more about this trial

Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

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