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
Study website
Contact information
Type
Public
Contact name
Dr Johannes Kersten
ORCID ID
Contact details
Albert-Einstein-Allee 23
Ulm
89071
Germany
+49 (0)73150045169
johannes.kersten@uni-ulm.de
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Secondary identifying numbers
CTO1
Study information
Scientific title
Prognostic value of cardiac magnetic resonance in patients with chronic total coronary occlusions
Acronym
Study hypothesis
The 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
Study design
Single-center prospective observational trial
Primary study design
Observational
Secondary study design
Longitudinal study
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Chronic total coronary occlusion (CTO)
Intervention
All 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 type
Procedure/Surgery
Primary outcome measure
Symptom burden with angina pectoris in repeated surveys using the Seattle Angina questionnaire (SAQ) at baseline and 3, 12, 24 and 36 months
Secondary outcome measures
Left 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 date
20/12/2017
Overall study end date
30/04/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients with angiographic proven CTO
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
100
Participant exclusion criteria
1. 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 date
16/04/2018
Recruitment end date
30/04/2021
Locations
Countries of recruitment
Germany
Study participating centre
Heart Clinic Ulm
Magirusstr. 49
Ulm
89077
Germany
Sponsor information
Organisation
Heart Clinic Ulm
Sponsor details
Magirusstr. 49
Ulm
89077
Germany
+49 (0)7319353070
peter.bernhardt@herzklinik-ulm.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Heart Clinic Ulm
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. 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
Intention to publish date
31/12/2024
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
Participant 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.
IPD sharing plan summary
Available on request
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 |