DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction

NCT ID: NCT01435408

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2024-12-31

Brief Summary

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This study focuses on Cardioprotective strategies.

Detailed Description

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Conditions

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ST Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional treatment.

Conventional primary PCI in STEMI.

Group Type ACTIVE_COMPARATOR

Conventional primary PCI

Intervention Type OTHER

Conventional primary PCI in STEMI with implantation of DES.

IPost

Ischemic postconditioning in STEMI.

Group Type EXPERIMENTAL

Ischemic postconditioning.

Intervention Type 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.

Deferred primary PCI.

Deferred strategy in STEMI.

Group Type EXPERIMENTAL

Deferred stenting in primary PCI.

Intervention Type OTHER

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

Interventions

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Conventional primary PCI

Conventional primary PCI in STEMI with implantation of DES.

Intervention Type OTHER

Ischemic postconditioning.

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.

Intervention Type OTHER

Deferred stenting in primary PCI.

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

Intervention Type OTHER

Other Intervention Names

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pPCI Ischemic postconditioning Mechanical postconditioning Deferred stenting

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Engstrom

MD, DMSci, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Koeber, Prof., DMSci

Role: PRINCIPAL_INVESTIGATOR

The Heart Center, Rigshospitalet, University of Copenhagen

Thomas Engstrom, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

The Heart Center, Rigshospitalet, University of Copenhagen

Henning Kelbaek, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

The Heart Center, Rigshospitalet, University of Copenhagen

Locations

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Department of Cardiology, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Department of Cardiology, Skejby University Hospital

Aarhus, , Denmark

Site Status

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, , Denmark

Site Status

Department of Cardiology, Gentofte University Hospital

Hellerup, , Denmark

Site Status

Department of Cardiology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 40391569 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35990971 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33951923 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31315939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31005537 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30354595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29776961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28595694 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28264870 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28249094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28069574 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27053444 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25965708 (View on PubMed)

Other Identifiers

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DANAMI-3

Identifier Type: -

Identifier Source: org_study_id

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