Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05632432

Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial

Led by Hospital District of Helsinki and Uusimaa · Updated on 2024-04-19

50

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

H

Hospital District of Helsinki and Uusimaa

Lead Sponsor

U

University of Helsinki

Collaborating Sponsor

AI-Summary

What this Trial Is About

Ischemic heart disease (IHD) is a leading cause of death worldwide, characterized by atherosclerotic plaques that reduce oxygen supply to the heart and can lead to heart attacks and heart failure. This trial evaluates a new therapy using the patient's own right atrial appendage (RAA) tissue to support heart repair during coronary artery bypass grafting (CABG) surgery. The study compares epicardial transplantation of atrial appendage micrografts (AAMs) to a control group receiving a collagen patch without AAMs, aiming to improve heart regeneration and reduce scarring. During CABG surgery, a piece of the RAA is safely removed and mechanically processed into AAMs, which are embedded in a fibrin gel and placed on a collagen-based patch. This patch is then sutured onto the heart's scarred area identified by preoperative cardiac MRI. The control group undergoes the same surgery but receives only the collagen patch without AAMs. The study enrolls 50 patients randomized equally between the two groups, with treatment and control procedures carried out under double-blinded conditions for patients and evaluating clinicians. Participants undergo assessments before surgery and at 3- and 6-month follow-ups, including blood tests for heart failure biomarkers, transthoracic and transesophageal echocardiography, cardiac MRI scans, symptom evaluations, and a six-minute walking test. Researchers will measure changes in heart scar tissue, heart function, and quality of life, along with monitoring safety events and feasibility of the therapy. The total study duration per participant is about six months, with careful data protection and ongoing safety monitoring throughout the trial.

CONDITIONS

Brief Title

Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent obtained
  • Left ventricular ejection fraction (LVEF) between 15% and 40% at recruitment (transthoracic echocardiography)
  • New York Heart Association (NYHA) Class II-IV heart failure symptoms
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Heart failure due to left ventricular outflow tract obstruction
  • Acute myocardial infarction within last 30 days
  • History of life-threatening or repeating ventricular arrhythmias, resuscitation, or implantable cardioverter-defibrillator
  • Stroke or other disabling condition within 3 months before screening
  • Severe valve disease or scheduled valve surgery
  • Renal dysfunction (GFR less than 45 ml/min/1.73m2)
  • Other disease limiting life expectancy
  • Contraindications for coronary angiogram or LGE-CMRI
  • Participation in another clinical trial
  • Screening failure if no visible scar or LVEF 50% or higher in preoperative cardiac MRI
  • Preoperative cardiac MRI not performed prior to scheduled CABG surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 8 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - CABG operation lasting approximately 3 to 5 hours

Participants undergo coronary artery bypass graft (CABG) surgery. During the surgery, a piece of the right atrial appendage (RAA) tissue is harvested. Depending on their group, participants receive either a collagen-based patch with autologous atrial appendage micrografts (AAMs) transplanted onto the scarred area of the heart or the collagen-based patch alone. Various intraoperative assessments are performed including transesophageal echocardiography.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 10 days for immediate post-operative safety monitoring; follow-up assessments at 3 months

Participants are monitored for safety and recovery, including telemetric rhythm monitoring for 4 days, and assessments of vasoactive medication use and infections up to 10 days after surgery. Cardiac function and symptoms are evaluated with transthoracic echocardiography at hospital discharge and 3-month follow-up visits.

1 hospital discharge visit and 1 follow-up visit at 3 months

Follow-up Assessments

Duration - 6 months post-surgery

Participants undergo comprehensive evaluations including late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI), blood and plasma sampling for biomarkers and epitranscriptomic analyses, symptom scaling, quality of life assessment, 6-minute walking test, and transthoracic echocardiography at 6 months after surgery to assess cardiac structure, function, and clinical outcomes.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit

Helsinki, Uusimaa, Finland, 00029

Actively Recruiting

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Research Team

A

Antti Nykänen, Docent

A

Antti E Vento, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017.

GBD 2017 Causes of Death Collaborators

https://pubmed.ncbi.nlm.nih.gov/30496103

Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling.

J N Cohn, R Ferrari, N Sharpe

https://pubmed.ncbi.nlm.nih.gov/10716457

Epidemiology of heart failure: the prevalence of heart failure and ventricular dysfunction in older adults over time. A systematic review.

Evelien E S van Riet, Arno W Hoes, Kim P Wagenaar...

https://pubmed.ncbi.nlm.nih.gov/26727047

Indications for coronary artery bypass surgery and percutaneous coronary intervention in chronic stable angina: review of the evidence and methodological considerations.

Charanjit S Rihal, Dominic L Raco, Bernard J Gersh...

https://pubmed.ncbi.nlm.nih.gov/14623791

Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Myocardial Infarction and Left Main or Multivessel Coronary Disease.

Pedro Freitas, Márcio Madeira, Luís Raposo...

https://pubmed.ncbi.nlm.nih.gov/30558758