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

• Sponsor: Vascular and Molecular Cardiology Society (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02818127
• Collaborator: Private Yenisehir Hospital (Other), Private Gozde Hospital (Other), Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)
• Enrollment: 2,000
• Locations: 3
• Arms: 5
• Duration (Months): 12
• Patients Per Site: 666.7
• Patients Per Site Per Month: 55.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Angiography; Coronary Artery Disease; Coronary Artery Ectasia; Slow-Flow Phenomenon; Coronary Heart Disease	Procedure: coronary angiography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method In Patients Undergoing Coronary Angiography
• Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: normal coronary artery coronary angiography will be performed by transfemoral or transradial route.	Procedure: coronary angiography; 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.
Active Comparator: coronary slow flow coronary angiography will be performed by transfemoral or transradial route.	Procedure: coronary angiography; 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.
Active Comparator: coronary artery ectasia coronary angiography will be performed by transfemoral or transradial route.	Procedure: coronary angiography; 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.
Active Comparator: non-obstructive coronary artery disease coronary angiography will be performed by transfemoral or transradial route.	Procedure: coronary angiography; 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.
Active Comparator: obstructive coronary artery disease coronary angiography will be performed by transfemoral or transradial route.	Procedure: coronary angiography; 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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of total coronary circulation time by using TIMI frame count method [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane Military Medical Academy	Ankara	Kecioren	Turkey
2	Private Gozde Hospital	Malatya		Turkey
3	Private Yenisehir Hospital	Mersin		Turkey

Sponsors and Collaborators

• Vascular and Molecular Cardiology Society
• Private Yenisehir Hospital
• Private Gozde Hospital
• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• von Lüdinghausen M. The venous drainage of the human myocardium. Adv Anat Embryol Cell Biol. 2003;168:I-VIII, 1-104. Review.

• Responsible Party: Vascular and Molecular Cardiology Society
• ClinicalTrials.gov Identifier: NCT02818127
• Other Study ID Numbers: Vasmol002
• First Posted: Jun 29, 2016
• Last Update Posted: Jul 12, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Coronary Aneurysm; No-Reflow Phenomenon

Study Results

No Results Posted as of Jul 12, 2016