---
title: COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
nct_id: NCT03214029
overall_status: ACTIVE_NOT_RECRUITING
sponsor: Hennepin Healthcare Research Institute
study_type: OBSERVATIONAL
primary_condition: Acute Myocardial Infarction
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03214029.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03214029"
ct_last_update_post_date: 2024-10-09
last_seen_at: "2026-05-12T07:09:42.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial

**NCT ID:** [NCT03214029](https://clinicaltrials.gov/study/NCT03214029)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 2000
- **Lead Sponsor:** Hennepin Healthcare Research Institute
- **Collaborators:** Abbott Diagnostics Division, Hennepin County Medical Center, Minneapolis
- **Conditions:** Acute Myocardial Infarction, Acute Coronary Syndrome
- **Start Date:** 2017-11-06
- **Completion Date:** 2025-12-31
- **CT.gov Last Update:** 2024-10-09

## Brief Summary

Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

## Detailed Description

Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.

Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Inclusion Criteria:

1. Adult, defined as subject 18 years of age or older
2. Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
3. At least one 12-lead electrocardiogram

Exclusion Criteria:

1. Currently pregnant
2. Trauma related admission
3. Cardiac arrest
4. Decline to participate
5. Did not present through the ED
6. Transferred from an outside hospital
```

## Arms

- **Study population** — Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.

## Interventions

- **Cardiac troponin testing** (DIAGNOSTIC_TEST) — Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

## Primary Outcomes

- **Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.** _(time frame: on admission)_ — Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction

## Secondary Outcomes

- **All-cause mortality** _(time frame: Up to 180-days)_
- **Cardiac death** _(time frame: Up to 180-days)_
- **Unstable angina** _(time frame: Up to 180-days)_
- **Acute myocardial infarction** _(time frame: Up to 180-days)_
- **Revascularization** _(time frame: Up to 180-days)_
- **Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.** _(time frame: 30-days)_

## Locations (1)

- Hennepin County Medical Center, Minneapolis, Minnesota, United States

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hennepin county medical center|minneapolis|minnesota|united states` — added _(2026-05-12)_
- `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)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03214029.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03214029*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*