NCT07126184

Brief Summary

Brief Summary: This study aimed to investigate the risk and factors that predict recurrent stroke in patients who initially had a stroke with no clear cause (called cryptogenic stroke) and were later found to have atrial fibrillation (AF), an irregular heart rhythm that can increase stroke risk. The study was conducted at Lady Reading Hospital in Peshawar, Pakistan, over five years from 2018 to 2023. Stroke is a leading cause of death and disability worldwide. In many cases, the cause of stroke is unclear, which makes it difficult to prevent it from happening again. Atrial fibrillation is a common hidden cause of such strokes but is often hard to detect because it can occur intermittently without symptoms. Detecting AF early is important because patients with AF benefit greatly from blood-thinning medicines (anticoagulants) that reduce the risk of another stroke. In this study, medical records of patients diagnosed with cryptogenic stroke were reviewed. Patients who were later diagnosed with atrial fibrillation within 12 months of their stroke were included. The researchers collected information about their age, gender, heart examinations, how and when AF was diagnosed, use of blood-thinning medicines, and if they had another stroke during follow-up. The study highlights the importance of early and prolonged heart rhythm monitoring in patients with cryptogenic stroke to detect atrial fibrillation. It also stresses the need for better access to and adherence to anticoagulant therapy in resource-limited settings like Pakistan to reduce the risk of recurrent stroke and improve patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

August 10, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Cryptogenic strokeAtrial FibrillationRecurrent Ischemic StrokeIschemic stroke

Outcome Measures

Primary Outcomes (1)

  • Incidence of Recurrent Ischemic Stroke

    Occurrence of new ischemic stroke confirmed by clinical assessment and neuroimaging during the follow-up period in patients initially diagnosed with cryptogenic stroke and later diagnosed with atrial fibrillation.

    5 years

Interventions

This observational study involved the use of standard cardiac monitoring methods to detect atrial fibrillation in patients initially diagnosed with cryptogenic ischemic stroke. Monitoring techniques included 12-lead ECG, 24-hour Holter monitoring, and implantable loop recorders (ILRs). No experimental interventions were assigned; patients received routine clinical care.

Eligibility Criteria

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

This study includes adult patients admitted to Lady Reading Hospital with cryptogenic ischemic stroke who were later diagnosed with atrial fibrillation within 12 months. The cohort was followed for recurrent stroke and clinical outcomes over a median of 13.8 months.

You may qualify if:

  • Adults aged 18 years or older.
  • Patients initially diagnosed with cryptogenic ischemic stroke confirmed by neuroimaging and standard diagnostic evaluation.
  • Patients subsequently diagnosed with atrial fibrillation within 12 months of index stroke, confirmed by ECG, 24-hour Holter monitoring, or implantable loop recorder.
  • Availability of complete clinical and follow-up data.

You may not qualify if:

  • Known history of atrial fibrillation or atrial flutter prior to the index stroke.
  • Presence of structural heart diseases, valvular abnormalities, or congenital cardiac anomalies.
  • Incomplete clinical or follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LRH/MTI

Peshawar, KPK, Pakistan

Location

MeSH Terms

Conditions

Ischemic StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 17, 2025

Study Start

January 1, 2018

Primary Completion

December 14, 2023

Study Completion

December 31, 2023

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations