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ST Segment Elevation Myocardial InfarctionDANAMI-3NCT01435408

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

A study testing Conventional primary PCI, Ischemic postconditioning. and Deferred stenting in primary PCI. in people with ST Segment Elevation Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study focuses on Cardioprotective strategies. Read more about this study

Who is it for?
Any age
What is being tested?
Conventional primary PCI, Ischemic postconditioning. and Deferred stenting in primary PCI.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
5 sitesDenmark
Study dates
Apr 2011to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Department of Cardiology, Aalborg University Hospital

    Aalborg, 9100

  • Department of Cardiology, Skejby University Hospital

    Aarhus, 8200

  • The Heart Center, Rigshospitalet, University of Copenhagen

    Copenhagen, 2100

  • Department of Cardiology, Gentofte University Hospital

    Hellerup, 2900

  • Department of Cardiology, Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment

This study focuses on Cardioprotective strategies.

Being tested
Conventional primary PCI, Ischemic postconditioning., Deferred stenting in primary PCI.
Keywords
STEMI, Ischemic postconditioning, Deferred stenting, Primary PCI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional primary PCIOther

    Also called pPCI

    Conventional primary PCI in STEMI with implantation of DES.

  • Ischemic postconditioning.Other

    Also called Ischemic postconditioning, Mechanical 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.

  • Deferred stenting in primary PCI.Other

    Also called Deferred stenting

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

Study groups in NCT01435408
Study groupRoleWhat they receive
Conventional treatment.Active comparatorConventional primary PCI in STEMI.
Receives: Other: Conventional primary PCI
IPostExperimentalIschemic postconditioning in STEMI.
Receives: Other: Ischemic postconditioning.
Deferred primary PCI.ExperimentalDeferred strategy in STEMI.
Receives: Other: Deferred stenting in primary PCI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality, heart failure (postconditioning)

    Measured: 2 years

Secondary outcomes (2)

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

    Infarct size Salvage index

    Measured: 3 month

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2016
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435408
Sponsor's protocol ID
DANAMI-3
Acronym
DANAMI-3
Status last verified
Mar 2023
First submitted
14 Sep 2011
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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 Mar 27;27(4):652-661. doi: 10.1093/ehjci/jeag001.

    PubMed 41493904

  • 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.

    PubMed 40391569

  • 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.

    PubMed 35990971

  • 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.

    PubMed 33951923

  • 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.

    PubMed 31315939

  • 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.

    PubMed 31005537

  • 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.

    PubMed 30354595

  • 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.

    PubMed 29776961

  • 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.

    PubMed 28595694

  • 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.

    PubMed 28264870

  • 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.

    PubMed 28249094

  • 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.

    PubMed 28069574

  • 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.

    PubMed 27053444

  • 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.

    PubMed 25965708

Questions about this trial

What is this clinical trial studying?

A study testing Conventional primary PCI, Ischemic postconditioning. and Deferred stenting in primary PCI. in people with ST Segment Elevation Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality, heart failure (postconditioning) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435408, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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