Heart Disease Trial, Recruiting NCT01311323 Sponsor: American Heart of Poland Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT01311323
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 years or older
  • People who have given written consent to participate
  • People diagnosed with a type of heart attack or severe chest pain (called Acute Coronary Syndrome without ST-segment elevation, including NSTEMI or unstable angina) that requires urgent investigation within 72 hours
  • People whose condition has been assessed as suitable for an invasive (surgical or procedural) treatment approach
  • People found to have significant blockages in two or more major heart arteries (including specific involvement of a key artery at the front of the heart, or three-vessel disease meeting certain measurement thresholds), as assessed by the treating team using specialised imaging and pressure-measurement tools
  • People for whom both open-heart bypass surgery (CABG) and a less invasive procedure to open blocked arteries (PCI) are both technically possible options
  • People for whom both a heart surgeon and an interventional heart specialist, working together as a team, have agreed that both treatment options are suitable

Who may not be able to join:

  • People under 18 years of age
  • People experiencing a particular type of heart attack involving full arterial blockage (STEMI), or a specific new abnormal heart rhythm pattern on their ECG (new left bundle branch block)
  • People with stable coronary artery disease rather than an acute (sudden/urgent) condition
  • People with blockages in only one or two arteries where the specific key artery at the front of the heart (proximal LAD) is not significantly affected
  • People whose condition is assessed as suitable for non-invasive (conservative/medication-only) treatment
  • People who are also expected to need surgery for a serious heart valve problem or other structural heart issue, particularly a moderate or severe leaking of the mitral valve
  • People who need an immediate emergency procedure to open a blocked artery
  • People whose coronary artery disease scores at or above a certain complexity threshold (Syntax Score of 33 or higher)
  • People who cannot take blood-thinning medications (antiplatelet therapy) either short-term or long-term
  • People experiencing severe acute heart failure or cardiogenic shock (the heart is unable to pump enough blood to the body)
  • People who have previously had bypass heart surgery (CABG)
  • People who have had a stenting or balloon procedure (PCI) within the past 6 months
  • People who have had a stroke (either caused by a clot or by bleeding in the brain) within the 6 months before joining
  • People with advanced kidney disease who are on dialysis
  • People who are pregnant, or intending to become pregnant (women of childbearing age will need a recent negative pregnancy test before being enrolled)
  • People with serious non-heart-related health conditions where life expectancy is estimated at less than 3 years
  • People currently participating in another clinical trial that has not yet reached its main study goal

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Piotr P Buszman, MD,PhD, Prof, American Heart of Poland

Phone: +48 667 132 233

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
American Heart of Poland
Registry
ClinicalTrials.gov
Start date
25 August 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

MACCE - Major Adverse Cardiac and Cerebral Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov