NCT02009527

Brief Summary

The present project is designed to test the hypothesis that arginase contributes to endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

December 8, 2013

Last Update Submit

April 17, 2015

Conditions

Coronary Artery DiseaseType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial function

    Flow-mediated dilatation of the radial artery

    20 min of reperfusion

Study Arms (2)

N-hydroxy-nor-arginine

EXPERIMENTAL

N-hydroxy-nor-arginine 0.1 mg/ min i.a. for 20 min

Drug: N-hydroxy-nor-arginine

NaCl

PLACEBO COMPARATOR

NaCl 0.9%, 6 ml/min i.a. for 20 min

Drug: NaCl

Interventions

N-hydroxy-nor-arginineDRUG
N-hydroxy-nor-arginine
NaClDRUG
NaCl

Eligibility Criteria

AgeUp to 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease

You may not qualify if:

  • Age \>80 years, Myocardial infarction/unstable angina within 6 weeks prior to the study, Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm, Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol, Participant in an ongoing study, Unwillingness to participate following oral and written information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Kovamees O, Shemyakin A, Pernow J. Effect of arginase inhibition on ischemia-reperfusion injury in patients with coronary artery disease with and without diabetes mellitus. PLoS One. 2014 Jul 29;9(7):e103260. doi: 10.1371/journal.pone.0103260. eCollection 2014.

    PMID: 25072937DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2

Interventions

N(omega)-hydroxynorarginine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John Pernow, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 12, 2013

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

SE(1)