An observational study in Coronary Chronic Total Occlusions, sponsored by Ospedale San Donato. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Ospedale San Donato · Observational
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.
Ospedale San Donato is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with angiographic evidence of CTO with planned PCI.
Exclusion Criteria:
At least ONE of the following: 1. Late gadolinium enhancement \<75%. 2. Improvement in segmental function ≥1 grade during low dose dobutamine
Procedure: PCI
At least ONE of the following: 1. Late gadolinium enhancement ≥75%. 2. No improvement in segmental function during low dose dobutamine
Procedure: PCI
At least ONE of the following: * perfusion defect (≥ 1,5 segments) assessed during peak infusion of adenosine or dobutamine * new wall motion abnormalities or worsening ≥1 grade during peak infusion of dobutamine
Procedure: PCI
None of conditions qualifying for the "Inducible ischemia group"
Procedure: PCI
percutaneous coronary intervention attempt
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%
Time frame: 12 +/- 3 months
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
Time frame: 12 +/- 3 months
Quality of life assessed by Seattle Angina Questionnaire (SAQ)
Delta SAQ score
Time frame: 12+/-3 months
Major cardiovascular events
all-cause death, death for cardiovascular cause, life-threatening arrythmia, hospitalization for heart failure, myocardial infarction, target vessel revascularization
Time frame: 12+/- 3 months
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
Time frame: 12 +/- 3 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ospedale San Donato