NCT07018778

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2025Sep 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

June 4, 2025

Last Update Submit

June 13, 2025

Conditions

Chronic Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    assessment of CMR and invasive data within 24hours

Secondary Outcomes (3)

  • Strain

    baseline CMR data

  • Tissue characterisation

    baseline CMR data

  • Cardiovascular Hospitalisation (CVH)

    12 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients referred to the clinical service for ischaemia evaluation

You may qualify if:

  • clinical indication for vasodilatator CMR or invasive coronar angiography
  • capability to give informed consent

You may not qualify if:

  • general: non-compliance, \<18 years of age, pregnancy
  • contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR \<30ml/min), allergies (medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, Hesse, 61231, Germany

Location

Central Study Contacts

Sören Jan Backhaus, MD

CONTACT

06032-996-2620s.backhaus@kerckhoff-klinik.de

Andreas Rolf, MD

CONTACT

06032-996-2620a.rolf@kerckhoff-klinik.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations

DE(1)