Heart Disease Trial, Recruiting NCT03497637 Sponsor: Helios Health Institute GmbH Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT03497637
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:

  • People who are older than 18 years of age
  • People who are willing to take part and are able to understand, read, and sign a consent form before any procedure takes place
  • People for whom a doctor has determined coronary angiography (an X-ray of the heart's arteries) and/or a procedure to open blocked arteries (PCI) is appropriate
  • People who have a narrowing of one or more of the heart's main arteries, where the narrowing is typically between 40–80% and where doctors are uncertain whether it is significantly affecting blood flow
  • People with stable chest pain (stable angina) or a recent heart event (acute coronary syndrome), noting that for heart attack patients, only arteries not directly responsible for the event are eligible, and only outside of the immediate emergency procedure
  • People who are already participating in another interventional study

Who may not be able to join:

  • People who have previously had heart bypass surgery (CABG) where the bypass grafts to the artery being examined are still working
  • People who have two separate narrowings in the same artery that are more than 10mm apart and would each need to be examined or treated individually
  • People who have a completely blocked artery
  • People whose heart and circulation are severely unstable (confirm with trial site)
  • People who have heavily calcium-hardened or unusually curved arteries
  • People who have a terminal illness with a life expectancy of less than 12 months
  • People who have had a major heart attack (STEMI) within 48 hours before the procedure
  • People who have serious disease affecting the heart valves
  • People whose recent heart event makes it difficult for doctors to identify which artery caused it
  • People who have a significant medical reason why a medication called adenosine cannot be used — for example, those with asthma
  • People who are pregnant

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 20 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: Holger Thiele, MD, Heart Center Leipzig - University Hospital

Phone: +49 341 865 1428

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
Helios Health Institute GmbH
Registry
ClinicalTrials.gov
Start date
23 October 2020
Est. completion
1 May 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Major Adverse Cardiac Event (MACE) rate

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: 20 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