Condition category
Circulatory System
Date applied
31/03/2020
Date assigned
01/04/2020
Last edited
01/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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 number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

20/12/2017

Overall trial end date

30/04/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All patients with angiographic proven CTO

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.herzklinik-ulm.de/index.html

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

IPD sharing statement
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.

Intention to publish date

31/12/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/04/2020: Trial's existence confirmed by the ethics committee of the Medical Association of Baden-Württemberg.