Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease

NCT04939207 | Recruiting DMC FDA Device

• 2 other identifiers: NL7739.100.21852002131
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 4

Brief Summary

Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks. Most patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan. Subjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period. The investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Angina pectoris; Coronary arteriosclerosis; CT scan; Cardiac catheterization; Coronary angiography; Myocardial fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Safety of non-invasive imaging techniques

  The number of Major adverse cardiovasculare events (MACE) as all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization in a 12 month follow-up period.

  12 months

Secondary Outcomes (6)

• Cost-effectiveness

  12 months

• Seattle Angina Pectoris Questionnaire

  12 months

• PHQ-9 Questionnaire

  12 months

• PROMIS-10 Questionnaire

  12 months

• Avoided coronary angiographies

  12 months

Study Arms (3)

CT-derived FFR

EXPERIMENTAL

In this study arm, the need for coronary revascularization will be determined by CT-derived Fractional Flow Reserve (FFR) calculations

Diagnostic Test: CT-FFR

Angiography-derived FFR

EXPERIMENTAL

In this study arm, the need for coronary revascularization will be determined by FFR-calculations derived from angiographic images

Diagnostic Test: Angiography-derived FFR

Routine Care

ACTIVE COMPARATOR

In this study arm, the need for coronary revascularization will be determined by angiography and invasive FFR-measurements

Diagnostic Test: Angiography with invasive FFR-measurements

Interventions

CT-FFR DIAGNOSTIC_TEST

CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree

CT-derived FFR

Angiography-derived FFR DIAGNOSTIC_TEST

FFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries

Angiography-derived FFR

Angiography with invasive FFR-measurements DIAGNOSTIC_TEST

during coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery.

Routine Care

Eligibility Criteria

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

You may qualify if:

• The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up
• The subject is clinically suspected of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.
• The subject has had ≥64 multidetector row coronary CTA or will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row coronary CTA.

You may not qualify if:

• The subject is suffering from unstable angina pectoris.
• The subject is suffering from decompensated congestive cardiac failure.
• The subject is suffering from a known non-ischemic cardiomyopathy.
• The subject has a history of PCI or CABG.
• The subject has had pacemaker or internal defibrillator leads implanted.
• The subject has a prosthetic heart valve.
• There is a severe language barrier.
• The subject participates in any other clinical trial that interferes with the current study.
• Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.
• The subject is or might be pregnant.
• The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:
• The subject is suffering from a cardiac rhythm other than sinus rhythm.
• The subject is morbidly obese (Body Mass Index (BMI) \> 40).
• The subject is not able to sustain a breath-hold for 25 seconds.
• The subject is unable to remain in supine position for at least 30 minutes.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• UMC Utrecht: collaborator

Study Sites (4)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Utrecht, 3584X, Netherlands

NOT YET RECRUITING

Related Publications (1)

• Peper J, Becker LM, Bruning TA, Budde RPJ, van Dockum WG, Frederix GWJ, Habets J, Henriques JPS, Houthuizen P, Mohamed Hoesein FAA, Planken RN, Voskuil M, Bots ML, Leiner T, Swaans MJ. Rationale and design of the iCORONARY trial: improving the cost-effectiveness of coronary artery disease diagnosis. Neth Heart J. 2023 Apr;31(4):150-156. doi: 10.1007/s12471-023-01758-3. Epub 2023 Jan 31.

  PMID: 36720801 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Angiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Martin J Swaans, Dr.

  St. Antonius Ziekenhuis Nieuwegein

  PRINCIPAL INVESTIGATOR

• Tim Leiner, Prof. Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin J Swaans, Dr.

CONTACT

+31 (0)88 320 0900; m.swaans@antoniusziekenhuis.nl

Mike Bosschaert, Drs.

CONTACT

+31 (0)88 320 0900; m.bosschaert@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: After coronary CT-scan, patients will be randomized in one of three possible study arms. One arm will receive additional CT-derived calculation of coronary blood flow, one arm will receive angiography-derived calculation of coronary blood flow and one arm will receive standard routine care. Standard care consists of coronary angiography and invasive coronary blood flow measurements. The results of these tests determine the need for treatment of coronary artery disease. After these tests, patients will be treated and followed according to routine care guidelines.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 25, 2021
• Study Start: March 22, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publishing the main study articles, raw and modified data can be made available at request
• Access Criteria: These criteria will be made in consultation with the legal advisor of our institution and have not yet been drafted. Specific degrees in the field of research have to be demonstrated, as wel as links with hospitals or research institutes of the researcher/physician (e.g. an employee contract)

Locations

NL (4)