Myocardial Ischemia Detection With a Combined Cardiovascular Magnetic Resonance and Biomarker Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Kantonsspital Olten
- Enrollment
- 772
- Locations
- 2
- Primary Endpoint
- Comparison of the number of positive cases of coronary artery disease using CMR combined stress test vs CMR standard stress test protocol.
Study Overview
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.
Detailed Description
Study Category and Rationale: This test falls into risk category A, since the medical device bears a conformity mark and is handled in clinical practice over a long period of time in accordance with the instructions for use. The drugs have also been in use in clinical routine for years.
Background and Rationale: For the diagnosis of CAD, we currently dispose sophisticated imaging techniques including cardiovascular magnetic resonance (CMR). In clinical routine, we often encounter the following issues: First, because of their availability and increasing uncertainty in the population, imaging modalities are increasingly used, even in patients with a low pretest probability for the presence of CAD, which is associated with high costs. Second, the diagnostic accuracy of the techniques is neither perfect nor equivalent between modalities, and there is an inherent testing risk.
Risk / Benefit Assessment: The benefit/risk relationship for our patients is high, as there is no specific study related risks. The risk of a study includes the risks of the trial intervention itself (CMR stress testing and insertion of a venous access with blood collections) as well as the risk of unauthorized data access through third parties or unwanted identification of participants. The benefit of this study may be an improvement in CMR stress testing for better diagnostic accuracy so that relevant ischemia is not missed or patients do not undergo coronary angiography unnecessarily.
Primary endpoint:
MR combined stress test vs CMR standard stress test protocol. As a primary analysis, we will compare the relative number of positive cases of CAD identified by the CMR test (number of patients positive on CMR and consecutive positive on angiography as a proportion of the total number of patients in the randomization group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Comparison of the number of positive cases of coronary artery disease using CMR combined stress test vs CMR standard stress test protocol.
Time Frame: 2 years
Coronary angiography is performed in patients with positive CMR results of both groups.
Secondary Outcomes
- 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)
Investigators
Nisha Arenja
PD Dr. med. Nisha Arenja Leitende Ärztin, Department of Cardiology, Kantonsspital Olten, Solothurner Spitäler AG Baslerstrasse 150, 4600 Olten, Switzerland
Kantonsspital Olten
