Myocardial Ischemia Detection With a Combined Cardiovascular Magnetic Resonance and Biomarker Protocol

NCT05813210 | Not Yet Recruiting

• 1 other identifier: Ischemia-CMR-Biomarker
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Early detection and treatment of coronary artery disease (CAD) can help curb the high incidence of cardiovascular disease, which is the leading cause of death worldwide. Today, we have sophisticated imaging techniques available to diagnose CAD, including cardiovascular magnetic resonance (CMR). CMR is able to detect relevant myocardial ischemia and guide treatment options. Therefore, it is recommended by the current guidelines for patients at intermediate risk. In clinical practice, we often encounter two main issues: first, because of their availability and increasing uncertainty in the population, imaging techniques are increasingly used, even in patients with a low pretest probability for the presence of CAD. Second, the diagnostic accuracy of the techniques is not perfect, and false-negative stress CMR perfusion studies are an important limitation of the method, especially in patients with advanced CAD and balanced ischemia. In addition, the standard method with pharmacologic testing carries an inherent risk. Aim: The aim of our project is to review the clinical pretest probability to reduce unnecessary imaging studies and to evaluate the improvement of diagnostic accuracy of CMR stress testing by adding exercise test and reviewing biomarkers, which could reduce the number of false-negative results, especially in patients with balanced ischemia, who usually suffer from severe CAD. Methodology: This is a prospective, randomized, two-arm, controlled, monocentric, national study performed in collaboration by two centers (Solothurner Spitäler AG and CRIB). Included are consecutive patients with suspected inducible myocardial ischemia who are examined by CMR at the Kantonsspital Olten and during the course also at the Bürgerspital Solothurn. Since all patients from the Kanton Solothurn are referred to us for CMR diagnosis, this represents an ideal referral pattern of unselected patients with a wide range of pretest probability for myocardial ischemia (interquartile range of pretest probability 20-60%). Patients able to exercise will randomized to either standard CMR stress protocol with regadenoson or to the combined CMR stress protocol, which includes additional exercise testing and measurement of hs-cTn, a biomarker for detecting myocardial damage. Patients with positive CMR results will be received to coronary angiogram. Potential Significance: This project has the potential to reduce the residual risk and thereby reduce cardiovascular mortality in patients with false-negative test result, especially those with balanced ischemia or inadequate response to vasodilatation drugs. In addition, the investigator will be able to make a statement about the additional use of biomarkers for the diagnosis of CAD in patients with stable condition. Thereby, the integrated use of biomarkers may improve the diagnostic accuracy and this might prevent unnecessary further strategies, which will reduce high-cost in health care systems. Furthermore, the investigator hopse for better patient selection in order to avoid unnecessary examinations in the future.

Conditions

Myocardial Ischemia Demand

Outcome Measures

Primary Outcomes (1)

• Comparison of the number of positive cases of coronary artery disease using CMR combined stress test vs CMR standard stress test protocol.

  Coronary angiography is performed in patients with positive CMR results of both groups.

  2 years

Secondary Outcomes (2)

• Patients tolerance of the test using modified Glasgow comfort score.

  1 year

• Number of rehospitalisation, cardiac interventions, acute myocardial infarction and death in both CMR stress protocols after 12 months of follow-up.

  2 years

Study Arms (2)

Combined stress test (pharmacological and physical stress)

EXPERIMENTAL

Patients are first stressed ergometrically and perfusion is assessed. Subsequently, drug induced stress perfusion is performed, as in the usual protocol.

Diagnostic Test: Exercise in combination with biomarkers and pharmacological stress CMR test

Pharmacological stress test

ACTIVE COMPARATOR

One group receiving only pharmacological stress test with Regadenoson.

Diagnostic Test: Exercise in combination with biomarkers and pharmacological stress CMR test

Interventions

Exercise in combination with biomarkers and pharmacological stress CMR test DIAGNOSTIC_TEST

A bicycle ergometry combined with pharmacoligical stress test is performed. High sensitive Troponin is taken before and after the stress test.

Combined stress test (pharmacological and physical stress); Pharmacological stress test

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients with suspected hemodynamic relevant myocardial ischemia with or without known CAD
• Patients able to give informed consent as documented by signature
• Patients able to physically able to exercise

You may not qualify if:

• Patients with acute coronary syndrome (ACS)
• Inability to exerciseInability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• Contraindications to CMR implantable devices, cerebral aneurysm clips, cochlear implants
• Severe Claustrophobia

Sponsors & Collaborators

• Kantonsspital Olten: lead

Study Sites (1)

Kantonsspital Olten

Olten, 4600, Switzerland

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: PD Dr. med. Nisha Arenja Leitende Ärztin, Department of Cardiology, Kantonsspital Olten, Solothurner Spitäler AG Baslerstrasse 150, 4600 Olten, Switzerland

Model Details: This is a prospective, randomized, two-arm controlled, monocentric, national study.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 14, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CH (1)