Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

NCT04748237 | Recruiting

• 1 other identifier: KIDS2020-1
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Acute Coronary Syndrome; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 5 year

Secondary Outcomes (14)

• Death or readmission because MI

  through study completion, an average of 5 year

• Death

  through study completion, an average of 5 year

• Cardiovascular death

  through study completion, an average of 5 year

• MI (fatal or non-fatal)

  through study completion, an average of 5 year

• Readmission because of unstable angina requiring revascularization

  through study completion, an average of 5 year

Study Arms (2)

Coronary computed tomopraphic angiography

EXPERIMENTAL

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 21 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.

Diagnostic Test: Coronary computed tomopraphic angiography

No Coronary computed tomopraphic angiography

NO INTERVENTION

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.

Interventions

Coronary computed tomopraphic angiography DIAGNOSTIC_TEST

CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

Coronary computed tomopraphic angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd Hospital

Stockholm, 18288, Sweden

RECRUITING

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Tomas Jernberg, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liselotte Persson, RN

CONTACT

+46812355000; Liselotte.Persson@sll.se

Henrik Löfmark, MD

CONTACT

Henrik.Lofmark@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Before adjudication, all documents will be masked regarding previous coronary computed tomographic angiography.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 10, 2021
• Study Start: January 21, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)