NCT03539133

Brief Summary

Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality. Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress68%
Oct 2017Jun 2030

Study Start

First participant enrolled

October 18, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

12.6 years

First QC Date

May 3, 2018

Last Update Submit

January 20, 2026

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

STEMIinfarctioncoronary artery diseasecomorbiditiesdiabetesanemia

Outcome Measures

Primary Outcomes (4)

  • Left-ventricular function

    * LV-EF \< 40% at 6 months * Δ LV-EF ≥ 5% between day 5 of hospitalization and 6 months

    6 months

  • Left-ventricular remodeling

    Δ LVEDV ≥ 20% or Δ LVESV ≥ 15% between day 5 of hospitalization and 6 months

    6 months

  • Myocardial texture

    * Infarct/Scar size \> 17.9% or MVO (yes) or IMH (yes) on day 5 of hospitalization or at 6 months * remote zone ΔECV between day 5 of hospitalization and 6 months

    on day 5 of hospitalization and 6 months

  • Patency rate

    Coronary patency rate

    6 months

Secondary Outcomes (3)

  • All cause mortaltiy

    12 months

  • MACCE

    12 months

  • Re-Hospitalisation due to heart failure

    12 months

Interventions

collection of clinical dataOTHER

prospectively and systematically collection of clinical research data from STEMI patients

Eligibility Criteria

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

Patients suffering from STEMI

You may qualify if:

  • Patients suffering from STEMI

You may not qualify if:

  • \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Related Publications (3)

  • Helten C, Benkhoff M, Mourikis P, Metzen D, Barcik M, Hu H, Ayhan A, Haurand J, Alde K, Duse D, Jung C, Hohlfeld T, Levkau B, Petzold T, Borst O, Becher S, Ommer-Blaesius M, Witkowski S, Lang A, Cramer M, Dannenberg L, Kelm M, Gerdes N, Polzin A. Acetylsalicylic acid improves outcome after acute myocardial infarction by reduction of thromboinflammation. J Thromb Haemost. 2026 Mar 4:S1538-7836(26)00119-4. doi: 10.1016/j.jtha.2026.02.003. Online ahead of print.

    PMID: 41791655DERIVED

  • Benkhoff M, Alde K, Ehreiser V, Dahlmanns J, Metzen D, Haurand JM, Duse DA, Jung C, Kelm M, Petzold T, Polzin A. Thromboinflammation is associated with clinical outcome after ST-elevation myocardial infarction. Blood Adv. 2024 Nov 12;8(21):5581-5589. doi: 10.1182/bloodadvances.2024014273.

    PMID: 39226457DERIVED

  • Bonner F, Jung C, Polzin A, Erkens R, Dannenberg L, Ipek R, Kaldirim M, Cramer M, Wischmann P, Zaharia OP, Meyer C, Flogel U, Levkau B, Godecke A, Fischer J, Klocker N, Kruger M, Roden M, Kelm M. SYSTEMI - systemic organ communication in STEMI: design and rationale of a cohort study of patients with ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2023 May 3;23(1):232. doi: 10.1186/s12872-023-03210-1.

    PMID: 37138228DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

prospectively defined blood sampling protocol

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionInfarctionCoronary Artery DiseaseDiabetes MellitusAnemia

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Christian Jung, MD, PhD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY CHAIR

Central Study Contacts

Christian Jung, MD, PhD

CONTACT

+492118118800christian.jung@med.uni-duesseldorf.de

Florian Bönner, MD,

CONTACT

+492118118800florian.boenner@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 29, 2018

Study Start

October 18, 2017

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

DE(1)