Clinical trial NCT01318629: Angina in Non Coronary Artery Disease
Official title: Invasive Findings in Patients With Angina Equivalent Symptoms But No Coronary Artery Disease; Results From the Heart Quest Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angina Pectoris
Microvascular Angina
Angina Pectoris, Variant
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 718
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008
* No significant coronary stenoses (no coronary stenoses ≥ 50%)

Exclusion Criteria:

* Severe valvular heart disease
* Severe congestive heart failure

Primary outcomes:
measure: Cause of angina equivalent symptoms in patients with no coronary artery disease
timeFrame: One day
measure: Prognosis of patients with angina equivalent symptoms and normal coronary arteries
timeFrame: 10 years after baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Paul Erne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schoenenberger 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.