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AzTrials

Chronic Total Occlusions of Coronary ArteriesStressECHOCTONCT07879573

Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization

An observational study of Chronic Total Occlusions of Coronary Arteries and Stress Echocardiography (SE), run by Assiut University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Nov 2026to 1 Jan 2029
How long will I take part?
1 Month
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Marghany Ahmed Marghany Hassan Mohammed, PHD contact

+2001285006001

ghnofer@gmail.com

Egypt1 site, 1 recruiting
  • Heart institute in Assuit university hospitals

    Asyut, Assuit, 71515

    Shimma Khedr, PHD, 2001001346551, s.khidr@aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Role of Stress Echocardiography-Derived Myocardial Work Indices, Inflammatory Biomarkers, and Procedural Techniques in Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization

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.

  1. 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.
Keywords
functional recovery, cto, stress echo, inflammatory biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 _ 3 years

Secondary outcomes (4)
  1. 1.To investigate the association between procedural technique and functional recovery, with exploration of potential mediation through acute inflammatory response.

    Measured: 2 - 3 years

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

    Measured: 2 - 3 years

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

    Measured: 2 - 3 years

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

    Measured: 2 - 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT07879573
Sponsor's protocol ID
StressECHOCTO
Acronym
StressECHOCTO
Status last verified
Oct 2026
First submitted
11 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Total Occlusions of Coronary Arteries and Stress Echocardiography (SE), run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Marghany Ahmed Marghany Hassan Mohammed, PHD (+2001285006001, ghnofer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07879573, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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