Coronary Artery EctasiaNCT02024919
Effect of Diltiazem on Coronary Artery Ectasia
A study testing intracoronary administration of diltiazem and intracoronary injection of 5 mL saline in people with Coronary Artery Ectasia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- intracoronary administration of diltiazem and intracoronary injection of 5 mL saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2012to May 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure <90 mmHg heart rate <60 atrioventricular block (grade > I) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School Of Medicine, Department of Cardiology
Ankara, 06230
About this study
Official title: Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study
Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart diseases are not present. CAE represents not only an anatomical variant but also a clinical constellation of coronary artery disease (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with CAE without significant coronary narrowing may still present with angina pectoris, positive stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion were demonstrated in ectatic coronary arteries.
Myocardial blush grading (MBG) technique has been utilized in various conditions such as acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated cardiomyopathy to evaluate myocardial perfusion.
Read more
There is still no consensus for management of CAE. Previously improvement of coronary flow has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent has been widely used in coronary catheter labs to prevent and treat no-reflow.
The current study with prospective design was therefore set up to assess whether epicardial flow and tissue level perfusion would be improved by diltiazem in myocardial regions subtended by the ectatic coronary arteries among patients with isolated CAE.
- Conditions
- Coronary Artery Ectasia
- Being tested
- intracoronary administration of diltiazem, intracoronary injection of 5 mL saline
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracoronary administration of diltiazemDrug
intracoronary injection of 5 mL salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem | Active comparator | intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline Receives: Drug: intracoronary administration of diltiazem |
| Saline | Placebo comparator | intracoronary saline 5 mL Receives: Drug: intracoronary injection of 5 mL saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blush grade
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
Measured: within 3 minutes after intracoronary diltiazem administration
TIMI (Thrombolysis in myocardial infarction) flow grade
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
Measured: Within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem
Measured: within 3 minutes after intracoronary administration of diltiazem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Ulaş Özcan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024919
- Sponsor's protocol ID
- AnkaraU1
- Status last verified
- May 2015
- First submitted
- 29 Dec 2013
- Last updated
- 6 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02024919
- Acronym / sponsor ID
- AnkaraU1
- Conditions
- Coronary Artery Ectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Dec 2013 (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.
Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart diseases are not present. CAE represents not only an anatomical variant but also a clinical constellation of coronary artery disease (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with CAE without significant coronary narrowing may still present with angina pectoris, positive stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion were demonstrated in ectatic coronary arteries.
Myocardial blush grading (MBG) technique has been utilized in various conditions such as acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated cardiomyopathy to evaluate myocardial perfusion.
There is still no consensus for management of CAE. Previously improvement of coronary flow has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent has been widely used in coronary catheter labs to prevent and treat no-reflow.
The current study with prospective design was therefore set up to assess whether epicardial flow and tissue level perfusion would be improved by diltiazem in myocardial regions subtended by the ectatic coronary arteries among patients with isolated CAE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diltiazem | Active comparator | Drug: intracoronary administration of diltiazemintracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline |
| Saline | Placebo comparator | Drug: intracoronary injection of 5 mL salineintracoronary saline 5 mL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure <90 mmHg heart rate <60 atrioventricular block (grade > I) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracoronary administration of diltiazem | Drug | Diltiazem |
| intracoronary injection of 5 mL saline | Drug | Saline |
Primary outcome
Myocardial blush grade
Time frame: within 3 minutes after intracoronary diltiazem administration
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
TIMI (Thrombolysis in myocardial infarction) flow grade
Time frame: Within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count
Time frame: within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracoronary administration of diltiazem and intracoronary injection of 5 mL saline in people with Coronary Artery Ectasia, run by Ankara University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2015. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial blush grade (time frame: within 3 minutes after intracoronary diltiazem administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 May 2015.