---
title: Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death
nct_id: NCT01102153
overall_status: COMPLETED
sponsor: University of Leipzig
study_type: OBSERVATIONAL
primary_condition: Cardiac Arrest
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01102153.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01102153"
ct_last_update_post_date: 2010-04-13
last_seen_at: "2026-05-12T07:11:29.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death

**Official Title:** NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

**NCT ID:** [NCT01102153](https://clinicaltrials.gov/study/NCT01102153)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** University of Leipzig
- **Conditions:** Cardiac Arrest, Hypothermia
- **Start Date:** 2008-04
- **Completion Date:** 2010-01
- **CT.gov Last Update:** 2010-04-13

## Brief Summary

Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

## Detailed Description

Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
* GCS 3

Exclusion Criteria:

* Non-cardiac sudden death
* Pregnancy
* Unstable circulation with high-dose inotropics
* Life-expectancy reducing concomitant illness
```

## Arms

- **Coolgard** — invasive cooling
- **ArcticSun** — non-invasive (surface) cooling

## Interventions

- **Coolgard** (DEVICE) — invasive cooling via femoral ICY-catheter
- **ArcticSun** (DEVICE) — non-invasive surface cooling by saline-cooled thermo-vest

## Primary Outcomes

- **neuron specific enolase (NSE) as a parameter for cerebral damage** _(time frame: 72 hours)_ — Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.

## Secondary Outcomes

- **neurologic outcome** _(time frame: 6 months)_
- **time to overall survival** _(time frame: one year)_

## Locations (2)

- University of Leipzig, Heart Center, Cardiology, Leipzig, Germany
- University of Leipzig, Heart Center, Cardiology, Leipzig, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of leipzig, heart center, cardiology|leipzig||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01102153.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01102153*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*