NCT02024919

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

December 29, 2013

Last Update Submit

May 5, 2015

Conditions

Coronary Artery Ectasia

Outcome Measures

Primary Outcomes (3)

  • Myocardial blush grade

    Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.

    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

    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

    within 3 minutes after intracoronary administration of diltiazem

Study Arms (2)

Diltiazem

ACTIVE COMPARATOR

intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline

Drug: intracoronary administration of diltiazem

Saline

PLACEBO COMPARATOR

intracoronary saline 5 mL

Drug: intracoronary injection of 5 mL saline

Interventions

intracoronary administration of diltiazemDRUG
Diltiazem
intracoronary injection of 5 mL salineDRUG
Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School Of Medicine, Department of Cardiology

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Aneurysm

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 29, 2013

First Posted

December 31, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

TU(1)