Normal, or Near Normal Coronary Angiography, Slow Coronary Flow, Stable Angina
Conditions
Keywords
Slow coronary flow phenomenon, Angina pectoris, chest pain, nicroandil
Brief summary
Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed opacification of epicardial arteries in the absence of significant arterial narrowing and blockade. Endothelial dysfunction at the level of microarteries have been proposed as the main pathological mechanism in this regard. Available evidence suggest that standard anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is hypothesized that anti-angina medications which exert vasodilatory effects in large coronary arteries as well as small dividing branches might be superior to nitroglycerin in amelioration of angina symptoms. The present randomized clinical trial was thus designed and conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina medication with effects on both large and small coronary vessels) with nitroglycerin in a group of patients with slow coronary flow presented with frequent angina episodes.
Interventions
DRUGNicorandil
nicorandil (10mg tablets, two times a day)
DRUGNitroglycerin
sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the three main coronary arteries; ( * a delayed opacification in at least one of the main coronary arteries was documented. Delayed opacification was defines as corrected TIMI frame count \> 23 fps
Exclusion criteria
* comorbid cardiovascular condition other than mild coronary atherosclerosis and coronary slow flow * refusal to participate * discontinuation of treatment * not returning for the follow up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angina Episode Frequnecy | 1 month | One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week. |
| Angina Episode Intensity | 1 month | One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced. |
| Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | 1 month | One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effects | 1 month | Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nitroglycerin sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) | 24 |
| Nicorandil nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Nicorandil: nicorandil (10mg tablets, two times a day) | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Nitroglycerin | Nicorandil | Total |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 13.3 | 54.6 years STANDARD_DEVIATION 11.1 | 54.4 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 4 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
Angina Episode Frequnecy
One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitroglycerin | Angina Episode Frequnecy | 2.28 episodes per week | Standard Deviation 0.15 |
| Nicorandil | Angina Episode Frequnecy | 1.68 episodes per week | Standard Deviation 0.15 |
Primary
Angina Episode Intensity
One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitroglycerin | Angina Episode Intensity | 3.89 units on a scale | Standard Deviation 0.3 |
| Nicorandil | Angina Episode Intensity | 3.03 units on a scale | Standard Deviation 0.29 |
Primary
Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nitroglycerin | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class I | 8 participants |
| Nitroglycerin | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class II | 11 participants |
| Nitroglycerin | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class III | 5 participants |
| Nicorandil | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class I | 19 participants |
| Nicorandil | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class II | 4 participants |
| Nicorandil | Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris | CCS Class III | 2 participants |
Secondary
Side-effects
Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications
Time frame: 1 month