NCT07879573 Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
| NCT ID | NCT07879573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Chronic Total Occlusions of Coronary Arteries |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-11-01 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07879573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Total Occlusions of Coronary Arteries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07879573 currently recruiting?
Yes, NCT07879573 is actively recruiting participants. Contact the research team at ghnofer@gmail.com for enrollment information.
Where is the NCT07879573 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT07879573 clinical trial?
NCT07879573 is sponsored by Assiut University. The trial plans to enroll 100 participants.