NCT02818127

Brief Summary

The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. This study also evaluates the relationship between the diseases in arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease and coronary venous pathologies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

June 27, 2016

Last Update Submit

July 10, 2016

Conditions

Coronary AngiographyCoronary Artery DiseaseCoronary Artery EctasiaSlow-Flow PhenomenonCoronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of total coronary circulation time by using TIMI frame count method

    1 day

Study Arms (5)

normal coronary artery

ACTIVE COMPARATOR

coronary angiography will be performed by transfemoral or transradial route.

Procedure: coronary angiography

coronary slow flow

ACTIVE COMPARATOR

coronary angiography will be performed by transfemoral or transradial route.

Procedure: coronary angiography

coronary artery ectasia

ACTIVE COMPARATOR

coronary angiography will be performed by transfemoral or transradial route.

Procedure: coronary angiography

non-obstructive coronary artery disease

ACTIVE COMPARATOR

coronary angiography will be performed by transfemoral or transradial route.

Procedure: coronary angiography

obstructive coronary artery disease

ACTIVE COMPARATOR

coronary angiography will be performed by transfemoral or transradial route.

Procedure: coronary angiography

Interventions

coronary angiographyPROCEDURE

Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.

coronary artery ectasiacoronary slow flownon-obstructive coronary artery diseasenormal coronary arteryobstructive coronary artery disease

Eligibility Criteria

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

You may qualify if:

  • Patients whom performed coronary angiography with a suspicion of coronary artery disease

You may not qualify if:

  • History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gulhane Military Medical Academy

Ankara, Kecioren, Turkey (Türkiye)

RECRUITING

Private Gozde Hospital

Malatya, Turkey (Türkiye)

RECRUITING

Private Yenisehir Hospital

Mersin, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • von Ludinghausen M. The venous drainage of the human myocardium. Adv Anat Embryol Cell Biol. 2003;168:I-VIII, 1-104. doi: 10.1007/978-3-642-55623-4.

    PMID: 12645157BACKGROUND

  • Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.

    PMID: 8598078BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary AneurysmNo-Reflow PhenomenonCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAneurysmIschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ertan Yetkin, MD

CONTACT

905327136721ertanyetkin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

TU(3)