Coronary Chronic Total Occlusions Clinical Trial
— CARISMA_CTOOfficial title:
Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions
| NCT number | NCT03152825 |
| Other study ID # | CARISMA_CTO |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 10, 2017 |
| Est. completion date | May 2023 |
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | May 2023 |
| Est. primary completion date | May 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Policlinico San Donato | San Donato Milanese | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Ospedale San Donato |
Italy,
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* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | CMR to identify re-occlusion of CTO | Correlate 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 |
12 +/- 3 months | |
| Primary | Left ventricular mechanical improvement after PCI | At least ONE of the following:
Delta ejection fraction = 5% Segmental function improvement =1 grade Delta end-diastolic volume = 10% Delta end-systolic volume = 10% |
12 +/- 3 months | |
| Secondary | Stress ischaemia improvement after PCI | At least ONE of the following stress CMR (adenosine or dobutamine) findings:
_<1.5 segments perfusion defect _=1 grade improvement in segmental wall motion abnormalities |
12 +/- 3 months | |
| Secondary | Quality of life assessed by Seattle Angina Questionnaire (SAQ) | Delta SAQ score | 12+/-3 months | |
| Secondary | Major cardiovascular events | all-cause death, death for cardiovascular cause, life-threatening arrythmia, hospitalization for heart failure, myocardial infarction, target vessel revascularization | 12+/- 3 months |