NCT01435408

Brief Summary

This study focuses on Cardioprotective strategies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

April 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

September 14, 2011

Last Update Submit

March 28, 2023

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMIIschemic postconditioningDeferred stentingPrimary PCI

Outcome Measures

Primary Outcomes (1)

  • All cause mortality, heart failure (postconditioning)

    2 years

Secondary Outcomes (2)

  • Infarct size in relation to area at risk as determined by MRI after 3 month

    3 month

  • All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy)

    1 year

Other Outcomes (7)

  • TIMI flow

    postprocedure

  • ST-segment resolution

    90 min postprocedure

  • Wall motion index (echo)

    1 year

  • +4 more other outcomes

Study Arms (3)

Conventional treatment.

ACTIVE COMPARATOR

Conventional primary PCI in STEMI.

Other: Conventional primary PCI

IPost

EXPERIMENTAL

Ischemic postconditioning in STEMI.

Other: Ischemic postconditioning.

Deferred primary PCI.

EXPERIMENTAL

Deferred strategy in STEMI.

Other: Deferred stenting in primary PCI.

Interventions

Conventional primary PCIOTHER

Conventional primary PCI in STEMI with implantation of DES.

Also known as: pPCI
Conventional treatment.
Ischemic postconditioning.OTHER

Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.

Also known as: Ischemic postconditioning, Mechanical postconditioning
IPost
Deferred stenting in primary PCI.OTHER

In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.

Also known as: Deferred stenting
Deferred primary PCI.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Acute onset of chest pain of \< 12 hours' duration.
  • ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel.

You may not qualify if:

  • Pregnancy.
  • Known intolerance of ASA, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Cardiology, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Department of Cardiology, Skejby University Hospital

Aarhus, 8200, Denmark

Location

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Department of Cardiology, Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Department of Cardiology, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (14)

  • Elezi B, Marquard JM, Kelbaek H, Nepper-Christensen L, Ahtarovski K, Kyhl K, Goransson C, Islam U, Kober L, Hofsten D, Pedersen F, Vejlstrup NG, Holmvang L, Engstrom T, Lonborg JT. Ten-year prognostic impact of cardiac magnetic resonance endpoints in patients with ST-segment elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2026 Jan 6:jeag001. doi: 10.1093/ehjci/jeag001. Online ahead of print.

    PMID: 41493904DERIVED

  • Marquard JM, Engstrom T, Kelbaek H, Beske RP, Islam U, Hofsten DE, Holmvang L, Pedersen F, Terkelsen CJ, Hoj Christiansen E, Tilsted HH, Glinge C, Jabbari R, Eftekhari A, Raungaard B, Clemmensen P, Botker HE, Jensen LO, Kober L, Lonborg JT. 10-Year Outcomes of Deferred or Conventional Stent Implantation in Patients With STEMI (DANAMI-3-DEFER). Circ Cardiovasc Interv. 2025 Jun;18(6):e015369. doi: 10.1161/CIRCINTERVENTIONS.125.015369. Epub 2025 May 20.

    PMID: 40391569DERIVED

  • Mazhar J, Ekstrom K, Kozor R, Grieve SM, Nepper-Christensen L, Ahtarovski KA, Kelbaek H, Hofsten DE, Kober L, Vejlstrup N, Vernon ST, Engstrom T, Lonborg J, Figtree GA. Cardiovascular magnetic resonance characteristics and clinical outcomes of patients with ST-elevation myocardial infarction and no standard modifiable risk factors-A DANAMI-3 substudy. Front Cardiovasc Med. 2022 Aug 3;9:945815. doi: 10.3389/fcvm.2022.945815. eCollection 2022.

    PMID: 35990971DERIVED

  • Ekstrom K, Nielsen JVW, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Ischemia From Nonculprit Stenoses Is Not Associated With Reduced Culprit Infarct Size in Patients with ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2021 May;14(5):e012290. doi: 10.1161/CIRCIMAGING.120.012290. Epub 2021 May 5.

    PMID: 33951923DERIVED

  • Nepper-Christensen L, Hofsten DE, Helqvist S, Lassen JF, Tilsted HH, Holmvang L, Pedersen F, Joshi F, Sorensen R, Bang L, Botker HE, Terkelsen CJ, Maeng M, Jensen LO, Aaroe J, Kelbaek H, Kober L, Engstrom T, Lonborg J. Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction. Heart. 2020 Jan;106(1):24-32. doi: 10.1136/heartjnl-2019-314952. Epub 2019 Jul 17.

    PMID: 31315939DERIVED

  • Ekstrom K, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Helqvist S, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Impact of Multiple Myocardial Scars Detected by CMR in Patients Following STEMI. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2168-2178. doi: 10.1016/j.jcmg.2019.01.032. Epub 2019 Apr 17.

    PMID: 31005537DERIVED

  • Nepper-Christensen L, Lonborg J, Hofsten DE, Ahtarovski KA, Bang LE, Helqvist S, Kyhl K, Kober L, Kelbaek H, Vejlstrup N, Holmvang L, Engstrom T. Benefit From Reperfusion With Primary Percutaneous Coronary Intervention Beyond 12 Hours of Symptom Duration in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2018 Sep;11(9):e006842. doi: 10.1161/CIRCINTERVENTIONS.118.006842.

    PMID: 30354595DERIVED

  • Falkentoft AC, Rorth R, Iversen K, Hofsten DE, Kelbaek H, Holmvang L, Frydland M, Schoos MM, Helqvist S, Axelsson A, Clemmensen P, Jorgensen E, Saunamaki K, Tilsted HH, Pedersen F, Torp-Pedersen C, Kofoed KF, Goetze JP, Engstrom T, Kober L. MR-proADM as a Prognostic Marker in Patients With ST-Segment-Elevation Myocardial Infarction-DANAMI-3 (a Danish Study of Optimal Acute Treatment of Patients With STEMI) Substudy. J Am Heart Assoc. 2018 May 18;7(11):e008123. doi: 10.1161/JAHA.117.008123.

    PMID: 29776961DERIVED

  • Lonborg J, Engstrom T, Ahtarovski KA, Nepper-Christensen L, Helqvist S, Vejlstrup N, Kyhl K, Schoos MM, Ghotbi A, Goransson C, Bertelsen L, Holmvang L, Pedersen F, Jorgensen E, Saunamaki K, Clemmensen P, De Backer O, Klovgaard L, Hofsten DE, Kober L, Kelbaek H; DANAMI-3 Investigators. Myocardial Damage in Patients With Deferred Stenting After STEMI: A DANAMI-3-DEFER Substudy. J Am Coll Cardiol. 2017 Jun 13;69(23):2794-2804. doi: 10.1016/j.jacc.2017.03.601.

    PMID: 28595694DERIVED

  • Topal DG, Lonborg J, Ahtarovski KA, Nepper-Christensen L, Helqvist S, Holmvang L, Pedersen F, Clemmensen P, Saunamaki K, Jorgensen E, Kyhl K, Ghotbi A, Schoos MM, Goransson C, Bertelsen L, Hofsten D, Kober L, Kelbaek H, Vejlstrup N, Engstrom T. Association Between Early Q Waves and Reperfusion Success in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: A Cardiac Magnetic Resonance Imaging Study. Circ Cardiovasc Interv. 2017 Mar;10(3):e004467. doi: 10.1161/CIRCINTERVENTIONS.116.004467.

    PMID: 28264870DERIVED

  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.

    PMID: 28249094DERIVED

  • Nepper-Christensen L, Lonborg J, Ahtarovski KA, Hofsten DE, Kyhl K, Ghotbi AA, Schoos MM, Goransson C, Bertelsen L, Kober L, Helqvist S, Pedersen F, Saunamaki K, Jorgensen E, Kelbaek H, Holmvang L, Vejlstrup N, Engstrom T. Left Ventricular Hypertrophy Is Associated With Increased Infarct Size and Decreased Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Jan 9;6(1):e004823. doi: 10.1161/JAHA.116.004823.

    PMID: 28069574DERIVED

  • Kelbaek H, Hofsten DE, Kober L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, De Backer O, Bang LE, Kofoed KF, Lonborg J, Ahtarovski K, Vejlstrup N, Botker HE, Terkelsen CJ, Christiansen EH, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Jensen LO, Clemmensen P, Grande P, Madsen JK, Torp-Pedersen C, Engstrom T. Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial. Lancet. 2016 May 28;387(10034):2199-206. doi: 10.1016/S0140-6736(16)30072-1. Epub 2016 Apr 3.

    PMID: 27053444DERIVED

  • Hofsten DE, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Clemmensen P, Torp-Pedersen C, Tilsted HH, Botker HE, Jensen LO, Kober L, Engstrom T; DANAMI 3 Investigators. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. Am Heart J. 2015 May;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004. Epub 2015 Feb 14.

    PMID: 25965708DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lars Koeber, Prof., DMSci

    The Heart Center, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Thomas Engstrom, MD, DMSci

    The Heart Center, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Henning Kelbaek, MD, DMSci

    The Heart Center, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSci, PhD

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 16, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2016

Study Completion

December 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

DK(5)