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Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI) (TCCT-TIMI)

Primary Purpose

Coronary Angiography, Coronary Artery Disease, Coronary Artery Ectasia

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

coronary angiography

About this trial

This is an interventional diagnostic trial for Coronary Angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Gulhane Military Medical AcademyRecruiting
Private Gozde HospitalRecruiting
Private Yenisehir HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

normal coronary artery

coronary slow flow

coronary artery ectasia

non-obstructive coronary artery disease

obstructive coronary artery disease

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02818127

First Posted

June 27, 2016

Last Updated

July 10, 2016

Sponsor

Vascular and Molecular Cardiology Society

Collaborators

Private Yenisehir Hospital, Private Gozde Hospital, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

1. Study Identification

Unique Protocol Identification Number

NCT02818127

Brief Title

Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)

Acronym

TCCT-TIMI

Official Title

Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method In Patients Undergoing Coronary Angiography

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vascular and Molecular Cardiology Society

Collaborators

Private Yenisehir Hospital, Private Gozde Hospital, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Angiography, Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Coronary Heart Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

normal coronary artery

Arm Type

Active Comparator

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Arm Title

coronary slow flow

Arm Type

Active Comparator

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Arm Title

coronary artery ectasia

Arm Type

Active Comparator

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Arm Title

non-obstructive coronary artery disease

Arm Type

Active Comparator

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Arm Title

obstructive coronary artery disease

Arm Type

Active Comparator

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

Intervention Type

Procedure

Intervention Name(s)

coronary angiography

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients whom performed coronary angiography with a suspicion of coronary artery disease Exclusion Criteria: History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ertan Yetkin, MD

Phone

905327136721

ertanyetkin@hotmail.com

Facility Information:

Facility Name

Gulhane Military Medical Academy

City

Ankara

State/Province

Kecioren

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Turgay Celik, MD

Phone

905326731032

benturgay@gmail.com

First Name & Middle Initial & Last Name & Degree

Turgay Celik, MD

First Name & Middle Initial & Last Name & Degree

Mustafa Demir, MD

First Name & Middle Initial & Last Name & Degree

Ali Osman Yıldırım, MD

First Name & Middle Initial & Last Name & Degree

Cengiz Öztürk, MD

Facility Name

Private Gozde Hospital

City

Malatya

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Izzet Tandogan, MD

First Name & Middle Initial & Last Name & Degree

Izzet Tandogan, MD

Facility Name

Private Yenisehir Hospital

City

Mersin

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ertan Yetkin, MD

Phone

905327136721

ertanyetkin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ertan Yetkin, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

12645157

Citation

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.

Results Reference

background

PubMed Identifier

8598078

Citation

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.

Results Reference

background

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Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)

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