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Stress CMR in Patients With Coronary Chronic Total Occlusions

Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03152825
Acronym
CARISMA_CTO
Enrollment
400
Registered
2017-05-15
Start date
2017-05-10
Completion date
2023-05-31
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Chronic Total Occlusions

Keywords

myocardial ischaemia, myocardial viability, coronary chronic total occlusions, cardiac magnetic resonance, stress CMR

Brief summary

A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of CTO lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. However, due to the higher rate of procedural complications and lower success rate of PCI than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or MI of \ 5%/year) and plausibly represent the best target for PCI. Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability. Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE \>75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion. This study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by CMR could identify patients who are more likely to benefit from PCI in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.

Interventions

PROCEDUREPCI

percutaneous coronary intervention attempt

Sponsors

Ospedale San Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Angiographic diagnosis of Coronary Chronic Total Occlusion (TIMI 0 lasting more than 3 months, if known) * baseline stress CMR * signed informed consent

Exclusion criteria

* CMR contraindications * severe CKD * contraindications to adenosine or dobutamine * unable/unwilling to sign informed consent * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular mechanical improvement after PCI12 +/- 3 monthsAt least ONE of the following: * Delta ejection fraction ≥ 5% * Segmental function improvement ≥1 grade * Delta end-diastolic volume ≥ 10% * Delta end-systolic volume ≥ 10%

Secondary

MeasureTime frameDescription
Stress ischaemia improvement after PCI12 +/- 3 monthsAt least ONE of the following stress CMR (adenosine or dobutamine) findings: \_\<1.5 segments perfusion defect \_≥1 grade improvement in segmental wall motion abnormalities
Quality of life assessed by Seattle Angina Questionnaire (SAQ)12+/-3 monthsDelta SAQ score
Major cardiovascular events12+/- 3 monthsall-cause death, death for cardiovascular cause, life-threatening arrythmia, hospitalization for heart failure, myocardial infarction, target vessel revascularization

Other

MeasureTime frameDescription
CMR to identify re-occlusion of CTO12 +/- 3 monthsCorrelate angiographic CTO re-occlusion and/or critical re-stenosis with at least ONE of the following stress CMR parameters: * Segmental perfusion defect ≥1.5 * New segmental contractility impairment * Delta ejection fraction, end-diastolic,end-systolic volume

Countries

Italy

Contacts

Primary ContactMassimo Lombardi, MD
massimo.lombardi@grupposandonato.it+390252774376
Backup ContactSilvia Pica, MD
silvia.pica@grupposandonato.it+390252774376

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026