Clinical trial NCT03152825: Stress CMR in Patients With Coronary Chronic Total Occlusions
Official title: Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Chronic Total Occlusions
Keywords: myocardial ischaemia
myocardial viability
coronary chronic total occlusions
cardiac magnetic resonance
stress CMR
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with angiographic evidence of CTO with planned PCI.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular mechanical improvement after PCI
timeFrame: 12 +/- 3 months
Secondary outcomes:
measure: Stress ischaemia improvement after PCI
timeFrame: 12 +/- 3 months
measure: Quality of life assessed by Seattle Angina Questionnaire (SAQ)
timeFrame: 12+/-3 months
measure: Major cardiovascular events
timeFrame: 12+/- 3 months
Other outcomes:
measure: CMR to identify re-occlusion of CTO
timeFrame: 12 +/- 3 months
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
affiliation: Policlinico San Donato
name: Massimo Lombardi, MD
role: PRINCIPAL_INVESTIGATOR
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