Magnetic resonance imaging vs invasive coronary angiography as first-line diagnostic modality in new-onset heart failure

Not Applicable

Completed

• Conditions: ewly diagnosed heart failure; Circulatory System

• Registration Number: ISRCTN16515058
• Lead Sponsor: German Cardiac Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-01-31
• Study Start: 2024-08-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

1. Age =18 years
2. Physical and mental ability to give informed consent
3. Written informed consent for study participation
4. Indication for coronary angiography and signed copies of patient information forms for coronary angiography and CMR
5. Heart failure with reduced ejection fraction and a left ventricular ejection fraction =40% in echocardiography (or comparable imaging modality) within the preceding 3 months
6. Cause of heart failure not yet determined
7. Hospital admission for coronary angiography for further evaluation of heart failure origin or in case of primary in-hospital diagnosis of HFrEF, clinical indication for coronary angiography after best possible cardiac recompensation

Exclusion Criteria

1. Pregnancy
2. End-stage renal disease (glomerular filtration rate <30 ml/min/m² (MDRD) and/or dialysis-dependency)
3. Acute coronary syndrome
4. History of coronary artery disease or myocardial infarction
5. Acutely decompensated heart failure or heart failure stage NYHA IV
6. Valvular stenosis (any) =grade II
7. Standard exclusion criteria for cardiac MRI (e.g., incompatible metallic implants or devices, known, claustrophobia, allergy against gadolinium-based contrast agents, bodily dimensions incompatible with scanner)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischaemic cause of heart failure diagnosed via CMR or CATH procedure used as the first modality at baseline

Secondary Outcome Measures

Name	Time	Method
umber of CATH procedures that could be avoided when applying the CMR-first strategy: this metric is operationalized as the number of patients in whom the CMR done as a first diagnostic test allowed the researchers to omit an invasive CATH procedure (measured at baseline)