NCT01853527

Brief Summary

The aim of the study is to assess presence of myocardial ischemia by contrast stress echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD) by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of myocardial ischemia in such patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 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

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

May 7, 2013

Last Update Submit

November 5, 2018

Conditions

Coronary AtherosclerosisMyocardial Ischemia

Keywords

CT coronary angiographyContrast stress echocardiographyArterial stiffnessQuality of lifeBiochemical and genetic markers

Outcome Measures

Primary Outcomes (1)

  • Presence of myocardial ischemia by contrast stress echocardiography

    Presence of delayed myocardial contrast enhancement during stress echocardiography

    15 minutes, during contrast stress echocardopgraphy

Secondary Outcomes (1)

  • Extent of myocardial ischemia by contrast stress echocardiography

    15 minutes, during contrast stress echocardiography

Study Arms (1)

Angina pectoris, non-obstructive CAD

Contrast stress echocardiography will be performed in patients with angina pectoris and non-obstructive CAD on CT-angiography to detect presence of myocardial ischemia

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population include 132 patients with symptomatic angina pectoris and non-obstructive coronary artery disease detected by CT-coronary angiography

You may qualify if:

  • Age \>30 years
  • Chest pain and or functional dyspnoea with a duration \> 6 months
  • Non-obstructive coronary artery disease detected by CT coronary angiography

You may not qualify if:

  • Significant coronary artery stenosis or normal coronary arteries by CT coronary angiography
  • Unstable coronary artery disease
  • Significant valvular heart disease
  • Mechanical valve prosthesis
  • Significant arrhythmia
  • Severly reduced pulmonary function (GOLD 3-4)
  • Known allergy to ultrasound contrast agents
  • Pregnancy
  • Inability to sign informed consent to participate
  • Other severe disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Heart Disease, Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (2)

  • Eskerud I, Gerdts E, Larsen TH, Simon J, Maurovich-Horvat P, Lonnebakken MT. Total coronary atherosclerotic plaque burden is associated with myocardial ischemia in non-obstructive coronary artery disease. Int J Cardiol Heart Vasc. 2021 Jun 30;35:100831. doi: 10.1016/j.ijcha.2021.100831. eCollection 2021 Aug.

    PMID: 34258383DERIVED

  • Lonnebakken MT, Eskerud I, Larsen TH, Midtbo HB, Kokorina MV, Gerdts E. Impact of aortic stiffness on myocardial ischaemia in non-obstructive coronary artery disease. Open Heart. 2019 May 4;6(1):e000981. doi: 10.1136/openhrt-2018-000981. eCollection 2019.

    PMID: 31217997DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urin test for biobank

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mai Tone Lønnebakken, MD, phd

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, phd

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 15, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

NO(1)