INVISIBLE-1 aims to prospectively follow patients up to one year after ischemic stroke to:
1. Determine the cumulative incidence of occult cancer in patients with embolic stroke of undetermined source (ESUS) and elevated D-dimer 2. Describe occult cancer characteristics and spontaneous course of occult cancer
Methodology
The investigators will include 370 stroke patients with elevated D-dimer (≥ 820 μg/L) at the time of stroke, suspicion of ESUS after initial workup and without known cancer. The investigators will perform a follow-up telephone interview at one year to assess the occurrence of a new cancer and characterize the course of the disease.
Significance
Determining the real incidence of occult cancer in high-risk patients will help support the implementation of screening trials in the future. Faster detection and treatment of occult cancers would significantly impact patient' outcomes by offering faster cancer treatment and optimal secondary stroke prevention.
Informed consent as documented by signature from patient or next of kin
Age ≥ 18 years old
Acute ischemic stroke with symptom onset within 48 h before admission
persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
Active cancer** known at time of index-stroke
Intravenous Thrombolysis administrated prior to D-dimer measurement: Use of external laboratory value possible if available
New diagnosis of central nervous system cancer
Patient or next of kin (in case of lacking capacity) unlikely to be compliant or available for study follow-up interview
This study aims to include 370 stroke-patients with elevated D-dimer (≥ 820 μg/L) at baseline and suspicion of ESUS after initial workup in emergency room.
Cohort
Prospective
Not listed
Number of participants with newly diagnosed cancer (occult cancer)
Determination of occult cancer characteristics
The description of the specific characteristics of occult cancers is defined by the location of the cancer, the histological type of cancer, the date of suspicion of cancer (e.g. via imaging), the type of investigation leading to the suspicion of cancer, the date of final diagnosis via histology, the presence of metastases at diagnosis, the type of treatment provided and the date of start of treatment.
Long-term functional outcome using the modified Rankin Scale (mRS) in stroke patients with occult cancer
The mRS (ranging from 0-6) measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The higher the mRS score, the more disabled or dependent the patient (mRS 6 represents death).
All-cause mortality rate and cause-specific mortality rate
Rate of recurrent ischemic stroke, or systemic embolism in occult cancer-related stroke
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