An observational study in Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE) and Inflammation Biomarkers, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Assiut University · Observational
Chronic total occlusion (CTO) is defined as complete coronary occlusion with TIMI flow grade 0 persisting for more than three months, identified in 15-25% of patients undergoing coronary angiography.¹,² CTO is associated with refractory angina, left ventricular dysfunction, and increased long-term mortality.³ Revascularization aims to restore anterograde flow and improve myocardial perfusion; however, functional recovery-a patient-centered endpoint-remains variable and poorly predicted.⁴ ,⁵ Available data demonstrate that left ventricular ejection fraction (LVEF) alone is insufficient.⁵ ,⁶ Cardiac magnetic resonance (CMR)-derived extracellular volume predicts recovery (OR 0.38; p=0.019), but CMR is not universally accessible.⁷ Stress echocardiography-derived myocardial work indices (GWI, GCW, GWE, GWW) have been validated in non-CTO populations, detecting dysfunction independent of LVEF and GLS, yet remain unstudied in CTO.⁸ ,⁹ Inflammatory biomarkers-monocyte-to-HDL ratio (MHR), soluble ST2 (sST2), and PIIINP-have shown prognostic value individually, but have not been integrated with myocardial work or procedural data.¹⁰ ,¹¹,¹² Procedural technique (antegrade vs. retrograde) affects procedural success but has not been evaluated as an independent predictor of functional recovery.¹³,¹⁴ The current strategy relies on fragmented, single-domain predictors, with no integrated pre-procedural model.
This research addresses that gap by combining mechanical (myocardial work), biological (MHR, sST2, PIIINP), and technical (procedural technique) domains into a unified predictive model. The rationale is that functional recovery is multifactorial, and an integrated model will outperform single-domain approaches, enabling better patient selection, procedural planning, and expectation setting.
Chronic total occlusion (CTO) is defined as a complete coronary artery occlusion with TIMI flow grade 0, known or suspected to have lasted for more than 3 months.¹ CTOs are identified in 15-25% of patients undergoing coronary angiography, representing a substantial and growing patient population.²,³ Clinical Consequences of CTOs
Clinical Consequences of CTOs:
Consequence Impact Angina Refractory to medical therapy in up to 40% of patients Left Ventricular Dysfunction Resulting from hibernation, stunning, and irreversible scar burden Mortality Independent predictor of long-term mortality 4 .
Quality of Life Impaired physical capacity and overall well-being
1.2 The Promise and Uncertainty of Revascularization Revascularization of CTOs aims to restore anterograde flow, improve myocardial perfusion, reduce ischemic burden, and enhance left ventricular function and exercise capacity.⁵,⁶ However, functional recovery-a patient-centered endpoint-is not universal, and predictors remain poorly defined.⁷,⁸ Central Research Question After restoring blood flow to a chronically occluded coronary artery, will the myocardium recover its function? This question lies at the heart of clinical decision-making, as not all patients experience functional recovery post-procedure.⁸ Identifying robust predictors of recovery is a clinical priority that can guide patient selection, procedural planning, and postprocedural expectations.
1.3 The Concept of Myocardial Recovery
Functional recovery after revascularization is contingent upon the presence of viable but dysfunctional myocardium, characterized by:
Term Definition Viability The presence of living, metabolically active myocytes that can resume function if reperfused Hibernation Chronic reversible contractile dysfunction due to sustained reduction in resting coronary blood flow Stunning Post-ischemic dysfunction that persists despite restoration of normal perfusion Functional Recovery Objective improvement in LVEF, wall motion, or exercise capacity after revascularization The extent to which each mechanism operates varies among patients and determines the recovery potential-a concept central to this proposal.⁷,⁸ 1.4 The Unifying Concept Functional recovery after CTO revascularization is multifactorial. A comprehensive predictive model must integrate mechanical, biological, and technical domains to accurately identify patients who will benefit most.
2. Motivation and Objectives 2.1 The Clinical Dilemma Challenge Why It Matters CTO affects 15-25% of CAD patients Large, growing population with limited predictive tools Revascularization is increasingly performed Outcomes remain variable, with unpredictable functional recovery Functional recovery is the patient-centered endpoint More meaningful than angiographic success alone Current prediction tools are fragmented No integrated, pre-procedural model exists
2.3 Specific Objectives
Primary Objective:
To develop an integrated predictive model combining stress echocardiography-derived myocardial work indices, inflammatory biomarkers (MHR, sST2, PIIINP), and procedural techniques to predict functional recovery after CTO revascularization.
Secondary Objectives:
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic and documented CTO confirmed by coronary angiography with TIMI 0 flow lasting ≥3 months
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Exclusion Criteria:
To develop an integrated predictive model combining stress echocardiography-derived myocardial work indices, inflammatory biomarkers (MHR, sST2, PIIINP), and procedural techniques to predict functional recovery after CTO revascularization.
Time frame: 2 _ 3 years
1.To investigate the association between procedural technique and functional recovery, with exploration of potential mediation through acute inflammatory response.
Time frame: 2 - 3 years
2.To determine the independent and relative contributions of each domain (mechanical, biological, technical) to functional recovery.
Time frame: 2 - 3 years
To evaluate the association between myocardial work indices and major adverse cardiovascular events (MACE) at 12 months.
Time frame: 2 - 3 years
To evaluate changes in health status and quality of life in relation to myocardial work recovery
Time frame: 2 - 3 years
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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