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RecruitingNCT07879573StressECHOCTOUpdated Oct 19, 2026

Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization

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

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. To investigate the association between procedural technique and functional recovery, with exploration of potential mediation through acute inflammatory response.
  2. To determine the independent and relative contributions of each domain (mechanical, biological, technical) to functional recovery .
  3. To explore the interaction effect between baseline Monocyte-to-HDL Ratio (MHR) and contractile reserve in predicting functional recovery
  4. To compare myocardial work stress echo indices along the inflammatory markers with traditional viability assessment.
02

Conditions studied

  • Chronic Total Occlusions of Coronary Arteries
  • Stress Echocardiography (SE)
  • Inflammation Biomarkers

Keywords

  • functional recovery
  • cto
  • stress echo
  • inflammatory biomarkers
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with symptomatic and documented CTO confirmed by coronary angiography with TIMI 0 flow lasting ≥3 months

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with symptomatic and documented CTO confirmed by coronary angiography with TIMI 0 flow lasting ≥3 months Age ≥18 years Referred for percutaneous coronary intervention (PCI) Provision of written informed consent

Exclusion criteria

Exclusion Criteria:

  • Acute myocardial infarction within 7days (as Acute inflammation contaminates biomarkers, within 7 days of an acute MI, sST2, MHR, and PIIINP values will reflect the acute infarction, not the chronic CTO state. the measured inflammatory response to a fresh myocardial injury, not the stable inflammatory milieu of a patient with a chronic total occlusion) and also stress test is contraindicated post-recent MI . Severe valvular heart disease (aortic stenosis with peak velocity ≥4.0 m/s or mean gradient ≥40 mmHg; mitral regurgitation graded severe; or any valvular lesion requiring imminent intervention)- because it independently alters myocardial work indices and is a contraindication to stress echocardiography ) and any significant valvular lesion that may independently affect LV function and alter myocardial stress indices . Contraindications to stress echocardiography Life expectancy \<1 year due to non-cardiac comorbidity, as determined by the treating physician(ethical burden on vulnerable patients and for study integrity) Active infection (until clinical resolution or normalization of CRP or a return to the patient's baseline inflammatory state , -2 months post-infection is used in some inflammatory profiling studies- ) Inflammatory disease Rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and similar conditions produce chronically elevated MHR and sST2 Atrial Fibrillation or Significant Arrhythmia (reliable myocardial work analysis cannot be performed without stable sinus rhythm. Hypertrophic Obstructive Cardiomyopathy or Significant LV Outflow Tract Obstruction (Dobutamine stress is contraindicated in HOCM because it can provoke dynamic obstruction and hemodynamic collapse . Additionally, HOCM independently alters myocardial work indices through pressure overload) Severe Renal Insufficiency (eGFR \<30 mL/min/1.73m²) sST2 and PIIINP are cleared partly by the kidney. In advanced renal failure, baseline levels are chronically elevated regardless of cardiac status, making ΔsST2 and ΔPIIINP uninterpretable Active Malignancy or Chemotherapy Within 6Months , Both sST2 and MHR are influenced by systemic inflammatory states, and chemotherapy directly alters monocyte counts, HDL levels, and fibrotic turnover Recent Stroke or Acute Neurological Event Within 3 Months sST2 is elevated after ischemic stroke and correlates with neurological deficit severity. MHR is also altered in acute stroke cohorts . Pregnancy (Standard precautionary exclusion)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 2.To determine the independent and relative contributions of each domain (mechanical, biological, technical) to functional recovery.

    Time frame: 2 - 3 years

  3. To evaluate the association between myocardial work indices and major adverse cardiovascular events (MACE) at 12 months.

    Time frame: 2 - 3 years

  4. To evaluate changes in health status and quality of life in relation to myocardial work recovery

    Time frame: 2 - 3 years

07

Study locations

1 of 1 sites recruiting
  • Heart institute in Assuit university hospitals
    Asyut, Assuit 71515, Egypt
    Recruiting
08

References and documents

Publications

  • 1. Niccoli G, Montone RA, Iannaccone M, Ielasi A, De Felice F, Porto I, et al. Inflammatory biomarkers and coronary no-reflow phenomenon after percutaneous coronary intervention. J Am Coll Cardiol. 2016;67(15):1801-1811. 2. Kato A, Minami Y, Katsura A, Muramatsu T, Fujita H, Matsumoto S, et al. Predictive value of high-sensitivity Creactive protein for long-term clinical outcomes after chronic total occlusion revascularization. Int J Cardiol. 2018;252:1-6. 3. Wilson WM, Walsh SJ, Bagnall AJ, Hoye A, Hanratty CG, Spratt JC. Clinical outcomes of antegrade versus retrograde approach in chronic total occlusion percutaneous coronary intervention. J Am Coll Cardiol. 2020;75(23):2895-2906. 4. Tabowei G, et al. Antegrade vs retrograde CTO-PCI: a meta-analysis of 21,276 patients. Catheter Cardiovasc Interv. 2024;103(2):245-258. 5. Rempakos A, Alexandrou M, Mutlu D, et al. Predicting Successful Chronic Total Occlusion Crossing With Primary Antegrade Wiring Using Machine Learning. JACC Cardiovasc Interv. 2024;17:1707-16. 6. Maestre-Luque LC, Gonzalez-Manzanares R, Gallo I, et al. Percutaneous Coronary Intervention for Chronic Total Occlusions Modulates Cardiac Hypoxic and Inflammatory Stress. J Clin Med. 2026;15(2):517. 7. Borovac JA, et al. Regional myocardial work in CTO-RCA patients. Eur Heart J Cardiovasc Imaging. 2026 (in press). 8. Korean J Radiol. Role of Myocardial Extracellular Volume Fraction Measured with Magnetic Resonance Imaging in the Prediction of Left Ventricular Functional Outcome after Revascularization of Chronic Total Occlusion of Coronary Arteries. Korean J Radiol. 2018;19(3):472-481. 9. Brugaletta S, Martin-Yuste V, Padro T, Alvarez-Contreras L, Otaegui I, García del Blanco B, et al. The role of inflammatory biomarkers in predicting functional recovery after chronic total occlusion revascularization. Rev Esp Cardiol. 2021;74(4):328-335. 10. Moroni F, Ammirati E, Magnoni M, D'Ascenzo F, Anselmino M, Anzalone N, et al. Inflammatory biomarkers and cardiovas

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 19, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2028
CompletionEst.
Jan 1, 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07879573
Lead sponsor
Assiut University
Responsible party
Ahmed Marghany Hassan Mohamed (DR.Ahmed Marghany Hassan Mohammed, Assiut University) — Principal investigator
First posted
Oct 19, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Ahmed Marghany Ahmed Marghany Hassan Mohammed, PHD
Contact
ghnofer@gmail.com
+2001285006001

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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