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Not yet recruiting NCT07737444

Association of Lipoprotein(a) With Postoperative Atrial Fibrillation

Observational POAF Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: POAF, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

About one in three patients who undergo open-heart surgery develop an irregular heart rhythm called postoperative atrial fibrillation (POAF). This condition increases the risk of stroke, prolongs hospital stays, and raises the chances of complications and death compared with patients who do not develop it. Because of these serious outcomes, researchers are working to identify which patients are most at risk. One potential blood marker is lipoprotein(a), or Lp(a). Higher levels of Lp(a) have been linked to abnormal heart rhythms in previous studies. We want to determine whether patients with elevated Lp(a) are more likely to develop POAF after heart surgery and better understand the biological mechanisms behind this risk. In this study, patients will be grouped based on whether they have high or low Lp(a) levels. All participants will wear a chest band monitor that continuously tracks heart rhythm for 3 months after surgery to detect POAF. During surgery, small tissue samples from the heart will also be collected. By examining these samples, we will assess whether patients with elevated Lp(a) show more scarring and inflammation which are two pathways known to cause abnormal heart rhythms. The goal of this study is to determine whether elevated Lp(a) increases susceptibility to POAF. This could help identify patients who may benefit from preventive treatments and closer monitoring. By understanding how Lp(a) affects heart tissue, we also hope to uncover the mechanisms that contribute to abnormal rhythm and guide the development of future targeted therapies to treat POAF and other heart rhythms.

Primary outcome measures

  • Lp(a) levels and POAF incidence [Time frame: 3 months post-operation]
  • Lp(a) Levels and POAF Burden [Time frame: 3 months post-operation]
Secondary outcome measures (3)
  • PAOF burden and atrial fibrosis and inflammation [Time frame: Tissue will be collected during surgery]
  • Lp(a) levels and atrial fibrosis and inflammation [Time frame: Tissue will be collected during surgery]
  • Lp(a) Levels and Serum Inflammatory Markers [Time frame: Blood will be collected at baseline, day 1 postoperative and day 30 pos-operative]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Scheduled for elective or urgent CABG, valve replacement, or combined CABG and valve replacement
  • Willing to wear the Skiin chest band for the duration of the study
  • Have a smartphone with an Operating System compatible with the
  • Skiin Connected Life App (Android 9+ or iOS 13+)

Exclusion criteria

  • Emergency indication for CABG, valve replacement, or combined CABG and valve replacement
  • Prior cardiac surgery
  • History of pre-operative persistent atrial fibrillation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07737444 · 128446 · 128446

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗