Magnetic resonance imaging in patients with chronic total occlusions of the coronary arteries

ISRCTN ISRCTN33203221
DOI https://doi.org/10.1186/ISRCTN33203221
Secondary identifying numbers CTO1
Submission date
31/03/2020
Registration date
01/04/2020
Last edited
13/07/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Atherosclerosis of the coronary arteries leads to coronary heart disease, a leading cause of mortality in developed countries. The narrowing of a coronary artery restricts the blood supply to the downstream heart muscle tissue. This can lead to the typical symptoms of chest pain, shortness of breath and a pumping weakness of the heart. A frequent finding in cardiac catheter exams is a chronic total occlusion of a coronary artery. The cardiac muscle tissue to be supplied can now die due to the insufficient bood supply or be in a kind of "sleep mode". If the heart muscle tissue is still alive, it would be worthwhile, according to the current state of knowledge, to reopen it. Therefore, vitality is assessed using cardiac magnetic resonance imaging (CMR). As far as possible and rational, the closed vessel would then be reopened in a cardiac catheter examination. This study aims to enhance patient selection for percutaneous coronary intervention (PCI) using CMR.

Who can participate?
Patients of the Heart Clinic Ulm with a chronic total coronary occlusion

What does the study involve?
The study has an observational design. Every patient is treated according to current guidelines. No additional invasive treatment or diagnostics are carried out. The success of the procedure is checked with an MRI. Quality of life and symptom severity are assessed before and repeatedly after revascularization using a questionnaire.

What are the possible benefits and risks of participating?
There are no expected benefits or risks of participating.

Where is the study run from?
Heart Clinic Ulm (Germany)

When is the study starting and how long is it expected to run for?
December 2017 to April 2024

Who is funding the study?
Heart Clinic Ulm (Germany)

Who is the main contact?
Dr Johannes Kersten
johannes.kersten@uni-ulm.de

Contact information

Dr Johannes Kersten
Public

Albert-Einstein-Allee 23
Ulm
89071
Germany

Phone +49 (0)73150045169
Email johannes.kersten@uni-ulm.de

Study information

Study designSingle-center prospective observational trial
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePrognostic value of cardiac magnetic resonance in patients with chronic total coronary occlusions
Study hypothesisThe aims of the current trial are:
1. To find CMR predictive factors including cut-off values for ischemia and viability regarding symptom improvement after CTO revascularization
2. To identify patients benefiting from CTO revascularization
3. To assess mid-term prognosis of event-free survival and quality of life in CTO patients undergoing revascularization
Ethics approval(s)Approved 16/04/2018, Ethics committee of the Medical Association of Baden-Württemberg (Landesärztekammer Baden-Württemberg, Ethik-Komission, Jahnstraße 40, 70597 Stuttgart, Germany; +49 (0)711-76989-0; ethikkommission@laek-bw.de), ref: F-2018-026
ConditionChronic total coronary occlusion (CTO)
InterventionAll patients with an angiographic proven CTO are screened for the study. After the CMR guided proof of viability and ischemia in the territory belonging to the CTO a first Seattle Angina Questionnaire (SAQ) for symptom severity is carried out. Then an attempt for revascularization by percutaneous coronary intervention (PCI) is done. In case of a non-successful PCI, more attempts are done when senseful. To examine the clinical benefit after successful PCI, more SAQ questionnaires were done after 3, 12, 24 and 36 months. To examine residual ischemia and a possible improvement in heart function, another CMR examination is done 3 up to 6 months after the CTO-PCI. Rates for major adverse cardiac events are recorded alongside the whole study period.
Intervention typeProcedure/Surgery
Primary outcome measureSymptom burden with angina pectoris in repeated surveys using the Seattle Angina questionnaire (SAQ) at baseline and 3, 12, 24 and 36 months
Secondary outcome measuresLeft and right ventricular ejection fractions, strain measurements and first-pass perfusion measured using a CMR scan at baseline and 3 up to 6 months after
Overall study start date20/12/2017
Overall study end date30/04/2024

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Participant inclusion criteriaAll patients with angiographic proven CTO
Participant exclusion criteria1. Myocardial infarctions in the last three months
2. Instable angina
3. Contraindications for CMR, gadolinium-based contrast agents or the intravenous administration of adenosine
4. Impaired renal function (glomerular filtration rate < 30ml/min)
5. Inability to give written informed consent
Recruitment start date16/04/2018
Recruitment end date30/04/2021

Locations

Countries of recruitment

  • Germany

Study participating centre

Heart Clinic Ulm
Magirusstr. 49
Ulm
89077
Germany

Sponsor information

Heart Clinic Ulm
Hospital/treatment centre

Magirusstr. 49
Ulm
89077
Germany

Phone +49 (0)7319353070
Email peter.bernhardt@herzklinik-ulm.de
Website http://www.herzklinik-ulm.de/index.html

Funders

Funder type

Hospital/treatment centre

Heart Clinic Ulm

No information available

Results and Publications

Intention to publish date31/12/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. Submission of the study protocol to a peer-reviewed journal in 2020
2. Interim results should be presented at the SCMR meeting in 2021
3. Publication of the final results is intended in a peer-reviewed international scientific journal in 2024
IPD sharing planParticipant level data are available from Dr Johannes Kersten (johannes.kersten@uni-ulm.de) on reasonable request. Personal data including name and address of the participants are erased therefore in the dataset. A clear assignment is still possible for the author via the study pseudonym.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Interim results article Baseline angina burden predicts quality of life and functional improvement in patients with viable myocardium treated for chronic total occlusion 12/07/2023 13/07/2023 Yes No

Editorial Notes

13/07/2023: Publication reference added.
01/04/2020: Trial's existence confirmed by the ethics committee of the Medical Association of Baden-Württemberg.