Chronic Coronary SyndromeNCT07018778
CMR-derived Quantitative Perfusion for Prediction of FFR
An observational study of Chronic Coronary Syndrome, run by Kerckhoff Klinik at 1 site in Germany.
Trial summary
Patients will undergo quantitative perfusion assessment in cardiovascular magnetic resonance imaging (dual bolus or dual sequence approach) as well as invasive coronary angiography for assessment of fractional flow reserve (FFR) including assessment of coronary flow reserve (CFR) and microcirculatory resistance (IMR). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Coronary Syndrome
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the clinical service for ischaemia evaluation
Who may be able to join
- clinical indication for vasodilatator CMR or invasive coronar angiography
- capability to give informed consent
Who cannot join
- general: non-compliance, <18 years of age, pregnancy
- contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quantification of Myocardial Blood Flow in Cardiovascular Magnetic Resonance for Prediction of Fractional Flow Reserve in Coronary Catheterisation
Patients will undergo quantitative perfusion assessment in cardiovascular magnetic resonance imaging (dual bolus or dual sequence approach) as well as invasive coronary angiography for assessment of fractional flow reserve (FFR) including assessment of coronary flow reserve (CFR) and microcirculatory resistance (IMR).
- Conditions
- Chronic Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CCS patients | Clinical patients referred for ischaemia testing (CMR/coronary angiogram) will undergo the respective counterpart as well so that patients will have undergone both CMR and invasive testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Perfusion
Correlation of myocardial blood flow and perfusion reserve in CMR with invasively dervived fractional flow reserve (FFR), coronary flow reserve (CFR) and microcirculatory resistance (IMR)
Measured: assessment of CMR and invasive data within 24hours
Dual bolus vs dual sequence
Compare both CMR-derived quantitative perfusion for prediction of FFR/CFR/IMR
Measured: assessment of CMR and invasive data within 24hours
Secondary outcomes (3)
Strain
Correlation of segmental perfusion and myocardial strain
Measured: baseline CMR data
Tissue characterisation
Correlation of segmental perfusion and T1/T2/ECV/LGE
Measured: baseline CMR data
Cardiovascular Hospitalisation (CVH)
CVH within 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018778
- Sponsor's protocol ID
- AZ 107/24
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Myocardial Blood Flow in Cardiovascular Magnetic Resonance for Prediction of Fractional Flow Reserve in Coronary Catheterisation
- ClinicalTrials.gov ID
- NCT07018778
- Acronym / sponsor ID
- AZ 107/24
- Conditions
- Chronic Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kerckhoff KlinikUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will undergo quantitative perfusion assessment in cardiovascular magnetic resonance imaging (dual bolus or dual sequence approach) as well as invasive coronary angiography for assessment of fractional flow reserve (FFR) including assessment of coronary flow reserve (CFR) and microcirculatory resistance (IMR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCS patients | – | –Clinical patients referred for ischaemia testing (CMR/coronary angiogram) will undergo the respective counterpart as well so that patients will have undergone both CMR and invasive testing. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the clinical service for ischaemia evaluation
Key inclusion criteria (2 listed)
- clinical indication for vasodilatator CMR or invasive coronar angiography
- capability to give informed consent
Key exclusion criteria (2 listed)
- general: non-compliance, <18 years of age, pregnancy
- contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Perfusion
Time frame: assessment of CMR and invasive data within 24hours
Correlation of myocardial blood flow and perfusion reserve in CMR with invasively dervived fractional flow reserve (FFR), coronary flow reserve (CFR) and microcirculatory resistance (IMR)
Dual bolus vs dual sequence
Time frame: assessment of CMR and invasive data within 24hours
Compare both CMR-derived quantitative perfusion for prediction of FFR/CFR/IMR
3 secondary outcomes
Strain
Time frame: baseline CMR data
Tissue characterisation
Time frame: baseline CMR data
Cardiovascular Hospitalisation (CVH)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome, run by Kerckhoff Klinik at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sören Jan Backhaus, MD (06032-996-2620, s.backhaus@kerckhoff-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Perfusion (time frame: assessment of CMR and invasive data within 24hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.