Angina PectorisHeartQuestNCT01318629
Angina in Non Coronary Artery Disease
An observational study of Angina Pectoris and Microvascular Angina, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Many patients undergoing coronary angiography are found to have no significant coronary artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic abnormalities suggestive of myocardial ischemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Microvascular Angina, Angina Pectoris, Variant
- How many people
- 718 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 1996to Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients who had coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 and who had no significant coronary stenoses (no coronary stenoses ≥ 50%) were recruited for this study.
Who may be able to join
- Coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008
- No significant coronary stenoses (no coronary stenoses ≥ 50%)
Who cannot join
- Severe valvular heart disease
- Severe congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invasive Findings in Patients With Angina Equivalent Symptoms But No Coronary Artery Disease; Results From the Heart Quest Cohort Study
Many patients undergoing coronary angiography are found to have no significant coronary artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically assess patients with angina equivalent symptoms despite normal coronary angiograms and to evaluate their symptoms according to a defined algorithm.
Read the detailed description
All consecutive patients who had coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 and who had no significant coronary stenoses (no coronary stenoses ≥ 50%) were recruited for this study. Patients are extensively examined during angiography using acetylcholine infusion and fast atrial pacing. According to the result of the additional invasive examination (vasospasm, vasoconstriction, vasodilation; symptoms during examination) a distinct diagnosis is attributed to the patients (small vessel disease, vasospastic disease, hypertensive heart disease, rhythm disorder, or extracardiac thoracic pain including pulmonary hypertension). Patients are followed-up after 10 years and prognosis of these patients is assessed (including mortality, cardiovascular events, re-angiography, functional status after 10 years).
- Medical subject headings
- Angina Pectoris, Microvascular Angina, Angina Pectoris, Variant
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of angina equivalent symptoms in patients with no coronary artery disease
Measured: One day
Prognosis of patients with angina equivalent symptoms and normal coronary arteries
Measured: 10 years after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJul 1996
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Paul Erne, Luzerner Kantonsspital
- Investigators
- Paul Erne, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318629
- Sponsor's protocol ID
- Heart Quest
- Acronym
- HeartQuest
- Status last verified
- Apr 2013
- First submitted
- 17 Mar 2011
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoenenberger AW, Adler E, Gujer S, Jamshidi P, Kobza R, Stuck AE, Resink TJ, Erne P. Prognostic value of an abnormal response to acetylcholine in patients with angina and non-obstructive coronary artery disease: Long-term follow-up of the Heart Quest cohort. Int J Cardiol. 2016 Oct 15;221:539-45. doi: 10.1016/j.ijcard.2016.07.035. Epub 2016 Jul 6.
PubMed 27414736Schoenenberger AW, Felber S, Gujer S, Moser A, Jamshidi P, Stuck AE, Erne P. Invasive findings in patients with angina equivalent symptoms but no coronary artery disease; results from the heart quest cohort study. Int J Cardiol. 2013 Jul 15;167(1):168-73. doi: 10.1016/j.ijcard.2011.12.053. Epub 2012 Jan 10.
PubMed 22236508
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Findings in Patients With Angina Equivalent Symptoms But No Coronary Artery Disease; Results From the Heart Quest Cohort Study
- ClinicalTrials.gov ID
- NCT01318629
- Acronym / sponsor ID
- HeartQuest / Heart Quest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Jul 1996
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 18 Mar 2011 (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.
Many patients undergoing coronary angiography are found to have no significant coronary artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically assess patients with angina equivalent symptoms despite normal coronary angiograms and to evaluate their symptoms according to a defined algorithm.
Detailed description
All consecutive patients who had coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 and who had no significant coronary stenoses (no coronary stenoses ≥ 50%) were recruited for this study. Patients are extensively examined during angiography using acetylcholine infusion and fast atrial pacing. According to the result of the additional invasive examination (vasospasm, vasoconstriction, vasodilation; symptoms during examination) a distinct diagnosis is attributed to the patients (small vessel disease, vasospastic disease, hypertensive heart disease, rhythm disorder, or extracardiac thoracic pain including pulmonary hypertension). Patients are followed-up after 10 years and prognosis of these patients is assessed (including mortality, cardiovascular events, re-angiography, functional status after 10 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who had coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 and who had no significant coronary stenoses (no coronary stenoses ≥ 50%) were recruited for this study.
Key inclusion criteria (2 listed)
- Coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008
- No significant coronary stenoses (no coronary stenoses ≥ 50%)
Key exclusion criteria (2 listed)
- Severe valvular heart disease
- Severe congestive heart failure
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
Cause of angina equivalent symptoms in patients with no coronary artery disease
Time frame: One day
Prognosis of patients with angina equivalent symptoms and normal coronary arteries
Time frame: 10 years after baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Derived from this study: PubMed 27414736Schoenenberger AW, Adler E, Gujer S, Jamshidi P, Kobza R, Stuck AE, Resink TJ, Erne P. Prognostic value of an abnormal response to acetylcholine in patients with angina and non-obstructive coronary artery disease: Long-term follow-up of the Heart Quest cohort. Int J Cardiol. 2016 Oct 15;221:539-45. doi: 10.1016/j.ijcard.2016.07.035. Epub 2016 Jul 6.
- Derived from this study: PubMed 22236508Schoenenberger AW, Felber S, Gujer S, Moser A, Jamshidi P, Stuck AE, Erne P. Invasive findings in patients with angina equivalent symptoms but no coronary artery disease; results from the heart quest cohort study. Int J Cardiol. 2013 Jul 15;167(1):168-73. doi: 10.1016/j.ijcard.2011.12.053. Epub 2012 Jan 10.
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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.
Paul Erne, MD principal investigator
Luzerner Kantonsspital
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 Angina Pectoris and Microvascular Angina, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 2 inclusion and 2 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 17 Apr 2013. 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 Switzerland. 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?
Cause of angina equivalent symptoms in patients with no coronary artery disease (time frame: One day). The study lists 2 primary outcomes in all. 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 NCT01318629, which also lists 2 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 17 Apr 2013.