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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01162902
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stable Angina	Drug: Diltiazem treated group; Drug: Bisoprolol treated group; Drug: Candesartan treated group	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
• Study Start Date: Sep 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diltiazem treated group Diltiazem 180mg treated group	Drug: Diltiazem treated group; Diltiazem 180mg for 9 months
Active Comparator: Bisoprolol treated group Bisoprolol 5mg treated group	Drug: Bisoprolol treated group; Bisoprolol 5mg for 9 months
Active Comparator: Candesartan treated group Candesartan 32mg treated group	Drug: Candesartan treated group; Candesartan 32mg for 9 months

Outcome Measures

Primary Outcome Measures

1. Wall to lumen ratio of fundus vessel [baseline, 9 months]

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

Secondary Outcome Measures

1. lipid parameter [baseline, 9 months]

   Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL

2. Serum markers of inflammation [baseline, 9 months]

   CRP

3. Change of nitrate need [baseline, 1 months, and 3 months]

   Measure of change of nitrate need

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01162902
• Other Study ID Numbers: ABC Trial
• First Posted: Jul 15, 2010
• Last Update Posted: Dec 17, 2013
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Angina, Stable; Vascular Remodeling; Candesartan; Diltiazem; Bisoprolol

Study Results

No Results Posted as of Dec 17, 2013