NCT00465868

Brief Summary

KoMPiS is a contrast aided cardiac magnetic resonance study of microvascular obstruction and left ventricular remodelling following acute revascularised anterior myocardial infarction. The study will monitor the included patients for 12 months following the acute myocardial infarct and collect data from MR scans and blood samples. The study is designed to demonstrate that obstruction of blood flow in the peripheral (small) vessels of the cardiac muscle is an important factor in the post-MI development of left ventricle dysfunction that occurs in many patients, despite of a successful re-opening of the occluded coronary artery that caused the MI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 28, 2015

Status Verified

June 1, 2008

Enrollment Period

2.4 years

First QC Date

April 24, 2007

Last Update Submit

July 27, 2015

Conditions

Heart Failure, Congestive

Keywords

Acute Myocardial InfarctionCoronary RevascularizationMicrovascular ObstructionCardiac MRCollagen TurnoverHeart failure, post-mi

Interventions

PCI (percutaneous coronary intervention)PROCEDURE

Outcome of PCI following AMI

Eligibility Criteria

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

Patients admited with AMi and rescue PCI.

You may qualify if:

  • Men or women \> 18 years of age, non-child bearing potential
  • First time acute myocardial infarction, as determined by evidence of transmural ischemia in the ECG and a rise in cardiac-Troponin-T (TNT) \> 0,1 (μg/l), followed by
  • A successful acute PCI of a single vessel disease with a proximal/mid left anterior descent artery (LAD), circumflex artery (RCX) or right coronary artery (RCA) lesion (the index PCI).

You may not qualify if:

  • Extensive cardiopulmonary resuscitation.
  • Haemodynamically unstable patients, unable to leave the coronary care unit for the CMR examination.
  • Use of fibrinolytics immediately prior to the index PCI.
  • Significant primary valve disease,
  • Autoimmune disease causing an increase in collagen turnover
  • Active cancer disease
  • Need for immunosuppressive treatment,
  • Significantly reduced liver function
  • Contraindications for performing a cardiac MRI-scan (claustrophobia, and implanted ferromagnetic devices, known allergic reactions to Omniscan™).
  • Inability to understand the consent form or cooperate during the 1 year follow up.
  • Comorbidity with poor prognosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (3)

  • Manhenke C, Ueland T, Jugdutt BI, Godang K, Aukrust P, Dickstein K, Orn S. The relationship between markers of extracellular cardiac matrix turnover: infarct healing and left ventricular remodelling following primary PCI in patients with first-time STEMI. Eur Heart J. 2014 Feb;35(6):395-402. doi: 10.1093/eurheartj/eht482. Epub 2013 Nov 18.

    PMID: 24255130DERIVED

  • Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K. Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J. 2009 Aug;30(16):1978-85. doi: 10.1093/eurheartj/ehp219. Epub 2009 Jun 6.

    PMID: 19502624DERIVED

  • Orn S, Manhenke C, Ueland T, Damas JK, Mollnes TE, Edvardsen T, Aukrust P, Dickstein K. C-reactive protein, infarct size, microvascular obstruction, and left-ventricular remodelling following acute myocardial infarction. Eur Heart J. 2009 May;30(10):1180-6. doi: 10.1093/eurheartj/ehp070. Epub 2009 Mar 19.

    PMID: 19299430DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

collagen markers, inflammatory markers and heart failure markers

MeSH Terms

Conditions

Heart Failure

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Kenneth Dickstein, PhD

    Universiy of Bergen, Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 28, 2015

Record last verified: 2008-06

Locations

NO(1)