ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

Launched by AARHUS UNIVERSITY HOSPITAL SKEJBY · Jun 10, 2018

Keywords

ClinConnect Summary

The ISCHEMIA-CTO Trial is studying the best treatment options for patients who have a condition called Chronic Total Occlusion (CTO) of a coronary artery, which means one of the heart's blood vessels is completely blocked. This trial aims to determine whether a procedure called Percutaneous Coronary Intervention (PCI), which uses special stents to open the blocked artery, is more effective than optimal medical therapy (OMT) in improving heart health and quality of life. The researchers are looking at two groups of patients: those who do not have symptoms but show signs of heart strain (myocardial ischemia) and those who do have symptoms.

To participate in this trial, individuals must be at least 18 years old and have specific heart conditions identified through imaging tests. They will first receive three months of medical therapy before being randomly assigned to either the PCI or OMT group. Participants can expect regular follow-ups to monitor their health over a period of up to five years for some groups. This study is currently recruiting and aims to involve around 1,560 patients. If you or someone you know might be eligible, it’s a great opportunity to contribute to important heart health research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CTO in native coronary artery
• • Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
• • Age ≥18 yrs.
• • Able to provide written informed consent and willing to comply with the specified follow-up contacts.
• • Target artery ≥ 2.5 mm
• Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:
• • Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO
• • Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO assess by nuclear imaging.
• • Cohort C: Screening population not eligible for randomization in cohort A or B
• Exclusion Criteria:
• • NSTEMI or STEMI within 1 month
• • Coronary anatomy not suitable for CTO-procedure
• • Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference.
• • Life expectancy \< 2 years
• • Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
• • Contraindication to dual anti-platelet therapy
• • Pregnancy
• • eGFR \< 30 mL/min/1.73 m2
• • In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
• • Severe valvular heart disease