Comparing heart procedures and medication for blocked coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of percutaneous coronary intervention (PCI) on patients with chronic total occlusion (CTO) of coronary arteries, comparing it to optimal medical therapy. The primary goal is to determine if PCI leads to a greater reduction in myocardial ischemia, as measured by exercise myocardial perfusion SPECT-CT, over a six-month period. Secondary objectives include assessing improvements in functional status, infarct size, and left ventricular function. Patients will be selected based on specific ischemic thresholds determined by cardiac imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:

   * A 100% luminal narrowing of the coronary artery without antegrade flow, i.e. Thrombolysis in Myocardial Infarction flow grade 0 or 1;
   * Older than 3 months, established with previous PCI or with angiographic characteristics;
   * Amenable to percutaneous revascularization.
2. Patient has a clinical indication to perform CTO PCI.
3. A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.

   The ischemic threshold is defined as:
   * \>12.5% of ischemia;
   * With \<50% transmural extent of infarction.
4. Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
5. Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion Criteria:

* Subject is younger than 18 years of age;
* Persistent or permanent atrial fibrillation;
* Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable cardioverter defibrillator;
* Body weight \> 250 kg;
* Unable to exert, i.e. due to physical disability;
* Any contraindication for SPECT or CMR, i.e. cerebrovascular clips, claustrophobia;
* Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<60 mL/min/1.73m2 or serum creatinine level of \>2.5 mg/dL or subject on dialysis);
* Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
* Presence of a comorbid condition with a life expectancy of less than one year;
* Participation in another trial;
* Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.

Where it's running

• Amsterdam UMC, location AMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Prof. J.P.S. Henriques, MD PhD
• Email: j.p.henriques@amc.uva.nl
• Phone: +31205666405

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a new guidewire system to treat blocked coronary arteries

  This study is testing a new guidewire system to see if it can help doctors treat blocked coronary arteries in patients who have had these blockages for over three months.

  Recruiting at 2 sites VasoStar, LLC · Atlanta, Georgia and 1 other locations · NCT06193954

• Comparing two approaches for treating blocked coronary arteries

  This study is testing two different methods for treating blocked coronary arteries to see which one works better and is safer for patients with chronic total occlusions.

  Recruiting at 30 sites Asan Medical Center · Anyang and 31 other locations · NCT03667196

• Comparing PCI and medical therapy for chronic total occlusion in heart disease

  This study is testing whether a new heart procedure using special stents can help people with blocked arteries feel better and have fewer heart problems compared to just taking medication.

  Recruiting at 14 sites Aarhus University Hospital Skejby · Aarhus N and 26 other locations · NCT03563417

• Registry for treating chronic total occlusion of coronary arteries in Japan

  This study is gathering information from patients in Japan who have had a specific heart procedure to treat blocked arteries, to see how to improve treatment for these cases.

  Recruiting Kurashiki Central Hospital · Kurashiki · NCT01889459

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.