- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162824
Blood Markers for Inflammation and Coronary Artery Vasoreactivity Testing in Patients With Chest Pain and Normal Coronary Arteries (ACOVA)
Correlation Between Abnormal Coronary Vasoreactivity Testing, Expansion of CD4+CD28null T Cells and Biomarkers for Inflammation and Endothelial Dysfunction in Patients With Angina Despite Angiographically Normal Coronary Arteries.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study comprises two parts:
- Blood sample
- ACH-test (including coronary flow measurements)
Blood will be taken, frozen and stored for up to 5 years. The following markers will be studied: C-reactive protein, E-selectin, neopterin, troponin and CD40 ligand. These are essential biochemical markers or so called pro-inflammatory substances that normally circulate in the blood but their levels can increase under certain conditions such as stress or inflammation. In addition, expansion of CD4+CD28null T-cells will be measured via flow cytometry.
Coronary angiography will be performed according to routine clinical guidelines. If the investigators find severe disease standard treatment procedures will take place and the investigators will only ask for a blood sample. If the investigators find normal coronary arteries on coronary angiography the investigators will conduct the ACH-test as part of the study. After injecting ACH into the coronary arteries narrowing can occur and provoke the same or similar symptoms as at home (i.e. chest pain). If you experience severe pain the investigators will inject a drug called nitroglycerine to relieve the pain. Then the investigators will measure the capacity of the blood vessels to dilate with a special catheter. The whole procedure including coronary angiography and ACH-test will last for about one hour. There is only very little radiation needed for the ACH-test which is unlikely to cause any health problems (~2.4mSv). In some very rare cases chest pain can be prolonged and heart rhythm disorders can occur. In worst case prolonged narrowing can lead to a heart attack (myocardial infarction, < 1%).
The result of the ACH-test can lead to 3 different results.
- Epicardial coronary spasm. This means that the narrowing of the blood vessel occurs in a place where it can be seen on the screen during angiography.
- Microvascular dysfunction This means that the narrowing of the blood vessel cannot be seen on the screen but on the ECG. It only affects the very small blood vessels of the heart.
- Normal ACH-test This means that the test is normal and the patient has no chest pain during the test and also no narrowing.
Depending on the result the investigators will suggest to start with a medication according to current guidelines and inform the patient's GP about the results and further suggestions for treatment. To maintain confidentiality all participants are entered onto our secure database using only their initials and a study number.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter E Ong, MD
- Phone Number: 2628 +44208725
- Email: pong@sgul.ac.uk
Study Contact Backup
- Name: Juan C Kaski, MD
- Phone Number: 2628 +44208725
- Email: jkaski@sgul.ac.uk
Study Locations
-
-
England
-
London, England, United Kingdom, SW17 0RE
- Recruiting
- Department of Cardiology, St George's Healthcare NHS Trust
-
Contact:
- Peter E Ong, MD
- Phone Number: 2628 +44208725
- Email: pong@sgul.ac.uk
-
Sub-Investigator:
- Peter E Ong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults of either gender > 35 years of age with a stable pattern of angina pectoris suggestive of coronary artery disease, with positive responses to exercise stress testing AND/OR patients with chest pain and ischaemic ST-segment changes during pain (previous obstructive coronary artery disease with or without stent-implantation will be allowed).
- Subjects will be invited to participate only if investigations have been undertaken to rule out non-cardiac causes for chest pain (i.e. oesophageal and musculoskeletal) previously.
- Serum creatinine < 123.7µmol/L.
- Left ventricular ejection fraction > 50%.
Exclusion Criteria:
- Chronic obstructive pulmonary disease.
- Cardiomyopathy.
- Severe valvular heart disease.
- Myocardial infarction within the last 3 months.
- Pregnant or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No endothelial dysfunction
|
Incremental doses of 2, 20 and 100 µg of ACH will be injected into the left coronary artery (LCA) via the diagnostic catheter for 3 minutes each.
After that 80 µg of ACH will be injected into the right coronary artery.
Coronary angiography will be performed after each 3 minute dose period.
After the test or when intolerable chest pain due to coronary spasm occurs, 0.2 mg of glyceryltrinitrate will be injected into each vessel.
During the test, heart rate, blood pressure and ECG will be monitored continuously.
Other Names:
Coronary blood flow velocity measurements will be performed in the mid segment of the left anterior descending artery with a 0.014-in intracoronary Doppler guidewire connected to the corresponding interface.
Measurements will be obtained after the administration of nitroglycerin, at baseline and during maximal hyperaemia.
Sustained intravenous administration of adenosine - an arteriolar vasodilator- will be used to induce maximal hyperaemia (140-180µg/kg/min).
|
Other: Endothelial Dysfunction
Definition of abnormal epicardial and microvascular vasoreactivity Abnormal epicardial vasoreactivity is defined as a reduction of the baseline coronary diameter ≥75% after glyceryltrinitrate i.c.
together with a reproduction of the angina symptoms reported by the patient and/or ischemic ECG-changes.
Abnormal microvascular vasoreactivity is defined as the reproduction of the angina symptoms together with ischaemic ECG-changes, but without changes in epicardial vasomotion.
|
Incremental doses of 2, 20 and 100 µg of ACH will be injected into the left coronary artery (LCA) via the diagnostic catheter for 3 minutes each.
After that 80 µg of ACH will be injected into the right coronary artery.
Coronary angiography will be performed after each 3 minute dose period.
After the test or when intolerable chest pain due to coronary spasm occurs, 0.2 mg of glyceryltrinitrate will be injected into each vessel.
During the test, heart rate, blood pressure and ECG will be monitored continuously.
Other Names:
Coronary blood flow velocity measurements will be performed in the mid segment of the left anterior descending artery with a 0.014-in intracoronary Doppler guidewire connected to the corresponding interface.
Measurements will be obtained after the administration of nitroglycerin, at baseline and during maximal hyperaemia.
Sustained intravenous administration of adenosine - an arteriolar vasodilator- will be used to induce maximal hyperaemia (140-180µg/kg/min).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial Dysfunction
Time Frame: Day 1 (day of study entry)
|
As this is not a follow-up study, the intracoronary vasoreactivity tests will be conducted at the day of study entry to assess which patient suffers from endothelial dysfunction. According to this result the patients will be divided into two groups (endothelial dysfunction and NO endothelial dysfunction). Definition of endothelial dysfunction: Vasoconstriction of >75% together with ischemic ECG changes and/or reproduction of angina OR ischemic ECG changes with reproduction of angina without vasoconstriction |
Day 1 (day of study entry)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan C Kaski, MD, Department of Cardiology, St George's Healthcare NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Ischemia
- Inflammation
- Atherosclerosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Cholinergic Agonists
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
- Acetylcholine
Other Study ID Numbers
- ACOVA-8
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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