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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01318629
Other study ID # Heart Quest
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 17, 2011
Last updated April 16, 2013
Start date July 1996
Est. completion date July 2018

Study information

Verified date April 2013
Source Luzerner Kantonsspital
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 718
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Switzerland Luzerner Kantonsspital Luzern

Sponsors (1)

Lead Sponsor Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cause of angina equivalent symptoms in patients with no coronary artery disease One day No
Primary Prognosis of patients with angina equivalent symptoms and normal coronary arteries 10 years after baseline assessment No
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