Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Seoul National University Hospital.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01162902

First received: April 30, 2010

Last updated: July 13, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2010

Last Updated Date

July 13, 2010

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Wall to lumen ratio of fundus vessel [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]

Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01162902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

lipid parameter [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Serum markers of inflammation [ Time Frame: baseline, 9 months ] [ Designated as safety issue: No ]
Measurement of change in the level of IL-6, IL-10, CRP, and MMP-9
Exercise capacity [ Time Frame: baseline, 1 month, and 9 months ] [ Designated as safety issue: No ]
Measurement of change of cardiopulmonary exercise capacity
Change of nitrate need [ Time Frame: baseline, 1 months, and 3 months ] [ Designated as safety issue: No ]
Measure of change of nitrate need

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Official Title ^ICMJE

Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Brief Summary

Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Stable Angina

Intervention ^ICMJE

Drug: Diltiazem treated group
Diltiazem 180mg for 9 months
Drug: Bisoprolol treated group
Bisoprolol 5mg for 9 months
Drug: Candesartan treated group
Candesartan 32mg for 9 months

Study Arm (s)

Experimental: Diltiazem treated group
Diltiazem 180mg treated group

Intervention: Drug: Diltiazem treated group
Active Comparator: Bisoprolol treated group
Bisoprolol 5mg treated group

Intervention: Drug: Bisoprolol treated group
Active Comparator: Candesartan treated group
Candesartan 32mg treated group

Intervention: Drug: Candesartan treated group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
Unstable Angina/NSTEMI patients who completed PCI for main lesions
Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

STEMI patients within one month
Variant Angina
Liver function abnormality or renal failure
History of Hypersensitivity to testing drugs
Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
Woman possible to be pregnant
Uncontrolled diabetes
Expected life span < one year

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hae-Young Lee, MD, PhD	82-10-4528-6160	hylee612@snu.ac.kr
Contact: Hyo-Soo Kim, MD, PhD	82-2-2072-2226	hyosoo@snu.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01162902

Other Study ID Numbers ^ICMJE

ABC Trial

Has Data Monitoring Committee

Yes

Responsible Party

Hyo-Soo, Kim, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Seoul National University Hospital

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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