Stroke Trial, Recruiting NCT06027788 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Stroke
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Stroke Trial, Recruiting

NCT06027788
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 60 years of age or older.
  • People who are planning to have a new or repeat open-heart surgery involving the aortic valve, mitral valve, or multiple heart valves, with or without coronary bypass surgery (certain specific combinations apply — confirm with trial site).
  • People whose planned surgery may also include a procedure to close off a small pouch in the heart (left atrial appendage closure) or a procedure to correct an irregular heartbeat (Maze procedure).
  • People who show no significant signs of neurological problems, based on standard medical assessments done within 30 days before joining the trial.
  • People who are able to understand and agree to take part, and who are able to follow the trial's requirements.

Who may not be able to join:

  • People who have had a clinical stroke in the 3 months before joining the trial.
  • People who have had imaging or a procedure involving the brain or aortic arch blood vessels within 3 days of the planned surgery.
  • People who have had a heart catheterisation within 3 days of the planned surgery and whose neurological assessment results were worse after that procedure compared to before it.
  • People who have an active heart valve infection (endocarditis) with visible growths on the valve at the time of joining the trial.
  • People who are showing signs of the heart failing to pump enough blood (cardiogenic shock), or who are receiving medication through a drip to support heart function, before joining the trial.
  • People who are already taking part in another clinical trial involving a drug or medical device.
  • People whose planned surgery involves repairing (not replacing) the mitral valve alone, repairing the tricuspid valve alone, or repairing both the mitral and tricuspid valves together.
  • People for whom the medical team expects they will need to remain on a breathing machine for more than 48 hours after surgery.
  • People who are also planned to have a separate neck artery procedure (carotid endarterectomy) at the same time as the heart surgery.

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 19 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: Annetine C. Gelijns, PhD, Icahn School of Medicine at Mount Sinai

Phone: 917-494-2387

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
Registry
ClinicalTrials.gov
Start date
18 September 2023
Est. completion
1 April 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI); Number of patients who experience of death and delirium

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: 19 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