Coronary Artery DiseaseNONCADNCT00926458
NON-Invasive Examinations of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Herning Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate and compare the value of 5 different non-invasive diagnostic methods in patients with chest pain suspected for coronary artery disease. The investigators intend to include 200 patients over a 3 year period in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jan 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred for coronary angiography at Region Hospital Herning are screened for the study and all patients complying with the in-/exclusion criteria are invited to participate in the study.
Who may be able to join
- Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
- Signed written informed consent
- Sinus rhythm (ECG)
- Age above 18 years
Who cannot join
- Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
- CA performed earlier in life
- Known significant cardiac valve disease
- Asthma (not COPD)
- Incapable of performing an exercise test
- Malignant Disease
Show all 17Show fewer
- Senile dementia or other conditions causing impaired cooperation
- Previous participation in the project
- NTG intolerance
- Pregnancy
- Bundle branch block (QRS > 120 ms)
- ECG changes:
- Pathologic Q-wave in at least two leads:
- QS-complex or Q-wave > 0.02 sec. in V2-V3
- QS-complex or Q-wave > 0.03 sec. and > 0.1 mV in I, II, aVL, aVF or V4-V6
- Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern
- Brady pacemaker
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Cardiovascular Research Unit, Regionhospital Herning
Herning, 7400
Ole May, MD, Ph.D., +4599272088, hecom@ringamt.dk
Ole May, MD, Ph.D., +4526175575, hecom@ringamt.dk
About this study
The aim of the study is to evaluate and compare the value of 5 different non-invasive diagnostic methods in patients with chest pain suspected for coronary artery disease. The investigators intend to include 200 patients over a 3 year period in the study. The participants will be recruited from patients referred to coronary angiography at the institution. Before the angiography the participants will (1) test the effect of sublingual Nitroglycerin, (2) give their medical history so mathematical models can estimate the probability of the presence of coronary artery disease, (3) take part in a contrast stress echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy. Stenosis found at the angiography will be the gold standard.
Read the detailed description
The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:
Substudy NITRO
Purpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.
The participants are instructed to alternate between rest and Nitroglycerine as treatment for chest pain attacks during a 2 week period. Chest pain score is recorded in a diary handed out at day 1 together with 30 tablets Nitroglycerine in the maximal tolerated dose.
Substudy SCORE
Aim: To test and compare the ability of different statistical methods using clinical data to predict the presence of narrowed coronary arteries in a contemporary Danish population.
Substudy CONTRAST
Aim: To evaluate if the blood flow in an area in the heart muscle measured by contrast adenosine stress echocardiography can predict the presence of significant stenosis in the coronary artery supplying the area.
Substudy 2D strain
Aim: To Evaluate if lack of increase in 2D strain during adenosine stress echocardiography can predict the presence of narrowed coronary arteries.
Substudy SPECT
Aim: To evaluate whether the result of a myocardial scintigraphy can predict symptomatic chest pain relief 6 months after a coronary angiography and possible treatment with balloon or bypass surgery.
Participants: Annually around 1,500 coronary angiographies are performed at Region Hospital Herning. We intend to include 200 patients referred by their physicians to coronary angiography in the study and expect the data collection phase to last 3 years.
- Conditions
- Coronary Artery Disease
- Keywords
- stress echocardiography, coronary angiography, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ole May, MD, Ph.D., Principal investigator, Cardiovascular Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926458
- Sponsor's protocol ID
- NONCAD
- Acronym
- NONCAD
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-Invasive Examinations of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00926458
- Acronym / sponsor ID
- NONCAD / NONCAD
- Conditions
- Coronary Artery Disease
- Keywords
- stress echocardiography, coronary angiography, coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate and compare the value of 5 different non-invasive diagnostic methods in patients with chest pain suspected for coronary artery disease. The investigators intend to include 200 patients over a 3 year period in the study. The participants will be recruited from patients referred to coronary angiography at the institution. Before the angiography the participants will (1) test the effect of sublingual Nitroglycerin, (2) give their medical history so mathematical models can estimate the probability of the presence of coronary artery disease, (3) take part in a contrast stress echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy. Stenosis found at the angiography will be the gold standard.
Detailed description
The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:
Substudy NITRO
Purpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.
The participants are instructed to alternate between rest and Nitroglycerine as treatment for chest pain attacks during a 2 week period. Chest pain score is recorded in a diary handed out at day 1 together with 30 tablets Nitroglycerine in the maximal tolerated dose.
Substudy SCORE
Aim: To test and compare the ability of different statistical methods using clinical data to predict the presence of narrowed coronary arteries in a contemporary Danish population.
Substudy CONTRAST
Aim: To evaluate if the blood flow in an area in the heart muscle measured by contrast adenosine stress echocardiography can predict the presence of significant stenosis in the coronary artery supplying the area.
Substudy 2D strain
Aim: To Evaluate if lack of increase in 2D strain during adenosine stress echocardiography can predict the presence of narrowed coronary arteries.
Substudy SPECT
Aim: To evaluate whether the result of a myocardial scintigraphy can predict symptomatic chest pain relief 6 months after a coronary angiography and possible treatment with balloon or bypass surgery.
Participants: Annually around 1,500 coronary angiographies are performed at Region Hospital Herning. We intend to include 200 patients referred by their physicians to coronary angiography in the study and expect the data collection phase to last 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for coronary angiography at Region Hospital Herning are screened for the study and all patients complying with the in-/exclusion criteria are invited to participate in the study.
Key inclusion criteria (4 listed)
- Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
- Signed written informed consent
- Sinus rhythm (ECG)
- Age above 18 years
Key exclusion criteria (17 listed)
- Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
- CA performed earlier in life
- Known significant cardiac valve disease
- Asthma (not COPD)
- Incapable of performing an exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole May, MD, Ph.D. principal investigator
Cardiovascular Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Herning Hospital at 1 site 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 17 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 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 23 Jun 2009.