NCT07737444

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 30, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

atrial fibrillationLp(a)InflammationFibrosis

Outcome Measures

Primary Outcomes (2)

  • Lp(a) levels and POAF incidence

    To determine whether patients with elevated preoperative Lp(a) levels (≥125 nmol/L) have a higher incidence of POAF, as detected by 3 months of continuous ECG monitoring.

    3 months post-operation

  • Lp(a) Levels and POAF Burden

    To determine whether patients with elevated preoperative Lp(a) levels (≥125 nmol/L) have a higher burden of POAF, defined as the total duration of AF episodes during the 3-month monitoring period.

    3 months post-operation

Secondary Outcomes (3)

  • PAOF burden and atrial fibrosis and inflammation

    Tissue will be collected during surgery

  • Lp(a) levels and atrial fibrosis and inflammation

    Tissue will be collected during surgery

  • Lp(a) Levels and Serum Inflammatory Markers

    Blood will be collected at baseline, day 1 postoperative and day 30 pos-operative

Study Arms (1)

Patients undergoing elective and urgent cardiac surgery with no history of persistent AF.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective and urgent cardiac surgery with no history of persistent atrial fibrillation.

You may qualify if:

  • 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+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Left atrial appendage and blood plasma

MeSH Terms

Conditions

Atrial FibrillationInflammationFibrosis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Scientific Director

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 30, 2026

Record last verified: 2026-05