Magnetic resonance imaging vs invasive coronary angiography as first-line diagnostic modality in new-onset heart failure
| ISRCTN | ISRCTN16515058 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16515058 |
| Secondary identifying numbers | Diagnostik Study |
- Submission date
- 21/08/2024
- Registration date
- 22/08/2024
- Last edited
- 14/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Newly diagnosed heart failure requires a comprehensive diagnostic work-up to determine its underlying cause. This work-up frequently includes a procedure called invasive coronary angiography (CATH). There are also alternatives, such as a non-invasive procedure called cardiac magnetic resonance imaging (CMR). The aim of this study is to find out whether CMR can diagnose the underlying cause of heart failure as well as CATH. If so, this would reduce the number of invasive procedures.
Who can participate?
Patients aged 18 years and over with newly diagnosed heart failure and a reduced left ventricular ejection fraction (i.e., below or equal to 40%, measured by echocardiography).
What does the study involve?
The study takes part in a routine clinical setting. All participants receive both diagnostic tests but the order is randomly allocated.
What are the possible benefits and risks of participating?
CATH is currently the standard procedure for newly diagnosed heart failure, so there is no added risk. CMR is a widely available diagnostic test which is non-invasive and involves the use of contrast media (as does CATH). Kidney function is closely observed during the study. The potential benefit is receiving an excellent diagnostic test (CMR), which in many instances can yield additional information that cannot be obtained by CATH.
Where is the study run from?
University Hospital Würzburg (Germany)
When is the study starting and how long is it expected to run for?
May 2015 to January 2024
Who is funding the study?
German Cardiac Society
Who is the main contact?
Prof. Dr. med. Stefan Störk, PhD, stoerk_s@ukw.de
Contact information
Public, Scientific, Principal Investigator
Am Schwarzenberg 15
Würzburg
97078
Germany
 ORCID ID |
0000-0002-1771-7249 |
|---|---|
| Phone | +49 (0)931 201 46362 |
| Stoerk_s@ukw.de |
Study information
| Study design | Randomized diagnostic controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | 45979_PIS_V1.3_30Aug19_German.pdf |
| Scientific title | Diagnostic value of cardiac magnetic resonance imaging vs coronary angiography as primary diagnostic strategy in heart failure with reduced ejection fraction – the randomized CMR-first/CATH-first study |
| Study acronym | DIAGNOSTIK STUDIE |
| Study objectives | Obtaining sufficient diagnostic information already from the first diagnostic procedure to satisfactorily establish or exclude ischemic origin of heart failure: “yes or no”, rendering the second diagnostic procedure redundant |
| Ethics approval(s) |
Approved 19/04/2018, Ethik-Kommission der Universität Würzburg (Versbacher Str. 9, Würzburg, 97078, Germany; +49 (0)931 31 48315; ethikkommission@uni-wuerzburg.de), ref: 298/17 |
| Health condition(s) or problem(s) studied | Newly diagnosed heart failure |
| Intervention | Participants are centrally randomised 1:1 to either coronary angiography first (CATH) followed by cardiac resonance imaging (CMR), or CMR first followed by CATH. Randomisation is done electronically in blocks, stratified based on left ventricular ejection fraction (LVEF) </=25 % vs >25 % according to the study-qualifying echocardiography. For endpoint evaluation, the results of each examination are presented separately to a CMR and a CATH expert panel, each blinded to the other procedure. The panel evaluates whether the cause of HF was ischemic and assesses the necessity to perform the other modality. Additionally, all examinations of both strategies (CATH-first and CMR-first) are also evaluated by the consulting cardiologist, who has access to all available data (clinical reference standard) and is blinded to the evaluation of the expert panels. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Ischaemic cause of heart failure diagnosed via CMR or CATH procedure used as the first modality at baseline |
| Secondary outcome measures | Number 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) |
| Overall study start date | 12/05/2015 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 229 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 22/11/2018 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- Germany
Study participating centres
Würzburg
97070
Germany
Leipzig
04103
Germany
Hannover
30625
Germany
Nürnberg
90471
Germany
Sponsor information
Other
Grafenberger Allee 100
Düsseldorf
40237
Germany
| Phone | +49 (0)211 600692-0 |
|---|---|
| info@dgk.org | |
| Website | https://dgk.org/ |
"ROR" |
https://ror.org/02p22ad51 |
Funders
Funder type
Research organisation
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- German Cardiac Society, Deutsche Gesellschaft für Kardiologie, Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e.V., DGK
- Location
- Germany
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published at the Late Breaking Trial Session at the ESC London, September 2024. |
| IPD sharing plan | The datasets generated and analysed during the current study can be made available upon request from Stefan Störk (stoerk_s@ukw.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 30/08/2019 | 22/08/2024 | No | Yes |
| Protocol file | version 1.6 | 14/01/2021 | 22/08/2024 | No | No |
| Results article | 12/07/2025 | 14/07/2025 | Yes | No |
Additional files
Editorial Notes
14/07/2025: Publication reference added.
21/08/2024: Study's existence confirmed by Ethik-Kommission der Universität Würzburg.
